FDA UDI
Not in Commercial Distribution
🇺🇸 United States
McKesson
DI: 40612479140125
·
Model: 25-460
·
MCKESSON MEDICAL-SURGICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- McKesson
- Primary DI
- 40612479140125
- Version / Model
- 25-460
- Company Name
- MCKESSON MEDICAL-SURGICAL INC.
- Labeler DUNS
- 023904428
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2020-04-20
- Public Version
- 2
- Public Version Date
- 2021-03-31
- Public Version Status
- Update
- Public Device Record Key
- b3d5716b-e762-4180-9860-fa61833e6bb1
- Distribution End Date
- 2020-04-21
Device Description
Calculi Strainers
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | Gastroenterology, Urology | 876.5250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14302 | Urine strainer | A device designed to collect stones (calculi) from urine during normal micturition (urination). It is typically designed as a sieve-like container with handles for holding and emptying, and is typically mounted into a funnel/holder system that may be attached to a dedicated treatment table or chair. The collected stones are typically sent to the clinical laboratory for examination and composition determination to facilitate patient diagnosis and/or therapy. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10612479239644 | GS1 | ||||
| Primary | 40612479140125 | GS1 |