HYPER (USP/EP) Water for Injection
HYPER| PACKAGED PRODUCT ANALYSIS | METHOD OF REFERENCE | SPECIFICATION | ||
|---|---|---|---|---|
| Appearance | Visual | Clear & Colorless Liquid | ||
| Total Organic Carbon | USP <643> | < 8000 ppb | ||
| Conductivity | USP <645> | ≤ 5 µS/cm | ||
| Endotoxin | USP <85> | ≤ 0.25 EU/mL | ||
| Sterility | USP <71> | No Growth | ||
| Particulate Matter | USP <788> |
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| Oxidizable Substances | EP Sterilized WFI | Solution remains faintly pink | ||
| Residue on Evaporation | EP Sterilized WFI | ≤ 3 mg (0.003%) | ||
| Nitrates | EP Sterilized WFI | ≤ 0.2 ppm |
| WFI Generation Online Analysis |
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WFI-USP |
|---|---|---|
| Conductivity (µS/cm) | ≤ 0.06 µS/cm | ≤ 1.3 µS/cm |
| TOC | ≤ 20 ppb | < 500 ppb |
ULTRA (USP) Water for Injection
ULTRA| PACKAGED PRODUCT ANALYSIS | METHOD OF REFERENCE | SPECIFICATION | ||
|---|---|---|---|---|
| Appearance | Visual | Clear & Colorless Liquid | ||
| Total Organic Carbon | USP <643> | < 8000 ppb | ||
| Conductivity | USP <645> | ≤ 5 µS/cm | ||
| Particulate Matter | USP <788> |
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Endotoxin | USP <85> | ≤ 0.25 EU/mL | |
| Sterility | USP <71> | No Growth |
| WFI Generation Online Analysis |
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WFI-USP |
|---|---|---|
| Conductivity (µS/cm) | ≤ 0.06 µS/cm | ≤ 1.3 µS/cm |
| TOC | ≤ 20 ppb | < 500 ppb |
WIR Water for Irrigation
WIR| PACKAGED PRODUCT ANALYSIS | METHOD OF REFERENCE | SPECIFICATION |
|---|---|---|
| Appearance | Visual | Clear & Colorless Liquid |
| Total Organic Carbon | USP <643> | < 8000 ppb |
| Conductivity | USP <645> | ≤ 5 µS/cm |
| Endotoxin | USP <85> | ≤ 0.25 EU/mL |
| Sterility | USP <71> | No Growth |
SPW Sterile Purified Water
SPW| PACKAGED PRODUCT ANALYSIS | METHOD OF REFERENCE | SPECIFICATION |
|---|---|---|
| Appearance | Visual | Clear & Colorless Liquid |
| Total Organic Carbon | USP <643> | < 8000 ppb |
| Conductivity | USP <645> | ≤ 5 µS/cm |
| Sterility | USP <71> | No Growth |
Sterile Fluid & Path Flush Syringes
Pre-filled Flush Syringes with 0.9% Sodium Chloride (Saline)
| Code Number | 510(k) Number | Device Number | Volume (fill) | Packaging |
|---|---|---|---|---|
| 2T0805 | K113555 | D218483 | 5mL | Sterile Fluid & Path |
| 2T0806 | K113555 | D218483 | 10mL | Sterile Fluid & Path |
| 2T0807 | K113555 | D218483 | 3mL | Sterile Fluid & Path |
Syringe Information
| Code Number | Capacity | Length (inches) | Width (inches) | Weight (lbs) |
|---|---|---|---|---|
| 2T0805 (5mL fill) | 12mL | 6.25" | 1.25" | 0.035 |
| 2T0806 (10mL fill) | 12mL | 6.25" | 1.25" | 0.045 |
| 2T0807 (3mL fill) | 12mL | 6.25" | 1.25" | 0.027 |
Case (shipper) Information
| Code Number | Quantity (case) | Cartons* per case | Carton* quantity |
|---|---|---|---|
| 2T0805 | 400 | 4 | 100 |
| 2T0806 | 400 | 4 | 100 |
| 2T0807 | 400 | 4 | 100 |
*carton aka box
Carton Dimensions
| Code Number | Length (inches) | Height (inches) | Width (inches) | Weight (lbs) |
|---|---|---|---|---|
| 2T0805 | 11" | 7.125" | 7.5" | 4.06 |
| 2T0806 | 11" | 7.125" | 7.5" | 5.06 |
| 2T0807 | 11" | 7.125" | 7.5" | 3.38 |
Case Dimensions
| Code Number | Length (inches) | Height (inches) | Width (inches) | Weight (lbs) |
|---|---|---|---|---|
| 2T0805 | 22.5" | 7.25" | 15.25" | 18 |
| 2T0805 | 22.5" | 7.25" | 15.25" | 22 |
| 2T0805 | 22.5" | 7.25" | 15.25" | 15.25 |
Sterile Field Ready Flush Syringes
Pre-filled Flush Syringes with 0.9% Sodium Chloride (Saline)
| Code Number | 510(k) Number | Device Number | Volume (fill) | Packaging |
|---|---|---|---|---|
| 2S0706 | K120836 | D218482 | 10mL | 100% Sterile (Sterile Field Ready) |
| 2S0708 | K133685 | D412001 | 20mL | 100% Sterile (Sterile Field Ready) |
Syringe Information
| Code Number | Capacity | Length (inches) | Width (inches) | Weight (lbs) |
|---|---|---|---|---|
| 2S0706 (10mL fill) | 12mL | 6.25" | 1.25" | 0.056 |
| 2S0708 (20mL fill) | 20mL | 7.00" | 1.95" | 0.086 |
Case (Shipper) Information
| Code Number | Quantity (case) | Cartons* per case | Carton* quantity |
|---|---|---|---|
| 2S0706 | 240 | 4 | 60 |
| 2S0708 | 80 | 4 | 20 |
*carton aka box
Carton Dimensions
| Code Number | Length (inches) | Height (inches) | Width (inches) | Weight (lbs) |
|---|---|---|---|---|
| 2S0706 | 11" | 7.125" | 7.5" | 3.52 |
| 2S0708 | 8.75" | 5.00" | 5.00" | 2.86 |
Documentation
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