FDA UDI
In Commercial Distribution
🇺🇸 United States
McKesson
DI: 20612479214969
·
Model: 163-89123
·
MCKESSON MEDICAL-SURGICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
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Basic Information
- Brand Name
- McKesson
- Primary DI
- 20612479214969
- Version / Model
- 163-89123
- Company Name
- MCKESSON MEDICAL-SURGICAL INC.
- Labeler DUNS
- 023904428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2020-04-16
- Public Version
- 1
- Public Version Date
- 2020-04-24
- Public Version Status
- New
- Public Device Record Key
- 3f179e40-9927-4e3d-8f0d-b072cd9458ad
Device Description
Premium Liquid Urine BOTTLE STYLE WITH MICROSCOPICS
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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJW | Urinalysis Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42065 | Urine sediment IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or semi-quantitative screening of urine sediment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10612479240855 | GS1 | ||||
| Primary | 20612479214969 | GS1 |