FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Vacutainer® Urine Collection Cups
DI: 50382903649759
·
Model: 364975
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
200
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Basic Information
- Brand Name
- BD Vacutainer® Urine Collection Cups
- Primary DI
- 50382903649759
- Version / Model
- 364975
- Catalog Number
- 364975
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 001292192
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2024-04-05
- Public Version
- 1
- Public Version Date
- 2024-04-15
- Public Version Status
- New
- Public Device Record Key
- f57c6eb6-71c3-473b-acff-1505e037287f
Device Description
CUP URIN COLLECTION BULK
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JTW | SYSTEM, TRANSPORT, AEROBIC | Microbiology | 866.2900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46023 | Non-evacuated urine specimen container IVD, no additive | A covered plastic receptacle with no additives intended to be used for the collection, and preservation and/or transport, of a urine specimen for 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00382903649754 | GS1 | ||||
| Primary | 50382903649759 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 35 Degrees Celsius