FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Vacutainer® Z (No Additive) Plus Urine Tube
DI: 30382903685012
·
Model: 368501
·
Becton, Dickinson U.K. Limited
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- BD Vacutainer® Z (No Additive) Plus Urine Tube
- Primary DI
- 30382903685012
- Version / Model
- 368501
- Catalog Number
- 368501
- Company Name
- Becton, Dickinson U.K. Limited
- Labeler DUNS
- 225931062
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2024-04-04
- Public Version
- 1
- Public Version Date
- 2024-04-12
- Public Version Status
- New
- Public Device Record Key
- db31b69b-2a7c-4d9b-ba1c-13d9917604cd
Device Description
TUBE URIN PLH 13X100 6.0 UA TAN
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMH | CONTAINER, SPECIMEN, STERILE | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58158 | Evacuated urine specimen container IVD, no additive | A covered receptacle containing a pre-measured amount of vacuum 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 in vitro diagnostic 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 | 50382903685016 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 30382903685012 | GS1 | ||||
| Unit of Use | 00382903685011 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius