FDA UDI
In Commercial Distribution
🇺🇸 United States
McKesson
DI: 00612479258693
·
Model: 16-364966UT
·
MCKESSON MEDICAL-SURGICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- McKesson
- Primary DI
- 00612479258693
- Version / Model
- 16-364966UT
- Company Name
- MCKESSON MEDICAL-SURGICAL INC.
- Labeler DUNS
- 023904428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2021-03-30
- Public Version
- 1
- Public Version Date
- 2021-04-07
- Public Version Status
- New
- Public Device Record Key
- 71b5a5d8-62f1-4b8b-ab43-51fb6f9b7103
Device Description
Urine transfer device
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EXG | Bag, Urine Collecting, Ureterostomy | Gastroenterology, Urology | 876.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58156 | Urine transfer IVD, sterile | A sterile plastic adaptor or dedicated transfer device, intended to be used to assist with the aseptic transfer of a urine specimen from the primary collection container to an evacuated urine specimen container for subsequent culture, analysis, and/or other investigation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00612479258709 | GS1 | Case | 6 | In Commercial Distribution | |
| Primary | 00612479258693 | GS1 | ||||
| Unit of Use | 00612479258686 | GS1 |