FDA UDI
Not in Commercial Distribution
🇺🇸 United States
McKesson
DI: 00612479199583
·
Model: 37-6280
·
MCKESSON MEDICAL-SURGICAL INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- McKesson
- Primary DI
- 00612479199583
- Version / Model
- 37-6280
- Company Name
- MCKESSON MEDICAL-SURGICAL INC.
- Labeler DUNS
- 023904428
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-12
- Public Version
- 4
- Public Version Date
- 2024-02-02
- Public Version Status
- Update
- Public Device Record Key
- a5ef0af6-e2fd-47dd-8b3f-91b8ccf9931b
- Distribution End Date
- 2024-02-01
Device Description
500 mL USP Sterile Saline, Screw Top Container
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U | |
| JOL | Catheter And Tip, Suction | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63285 | Multi-purpose therapeutic saline solution | A water-based salt solution (e.g., sodium chloride isotonic solution) intended for alternative use in multiple patient applications including inhalation therapy, moisturizing and washing/irrigation of the eyes, nose and ears, and wound cleansing; it is not dedicated to a specific application or part of the anatomy. It is typically available in a squeeze bottle for self-administration or application to infants for preventive or symptomatic care in the home. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00612479180307 | GS1 | Case | 18 | Not in Commercial Distribution | 2024-02-01 |
| Primary | 00612479199583 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K083042 | 000 |