FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Vacutainer® C&S Preservative Urine Tube
DI: 50382903649513
·
Model: 364951
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1000
Basic Information
- Brand Name
- BD Vacutainer® C&S Preservative Urine Tube
- Primary DI
- 50382903649513
- Version / Model
- 364951
- Catalog Number
- 364951
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 001292192
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2020-11-16
- Public Version
- 3
- Public Version Date
- 2021-07-22
- Public Version Status
- Update
- Public Device Record Key
- 13b2a56f-24df-4274-9e52-d5845aa9a584
Device Description
TUBE URIN PLC 13X75 4.0 C&S GR
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
- 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
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JSM | CULTURE MEDIA, NON-PROPAGATING TRANSPORT | Microbiology | 866.2390 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58151 | Evacuated urine specimen container IVD, preservative | A covered receptacle containing a pre-measured amount of vacuum and one or multiple preservatives [e.g., mercuric oxide, boric acid (H3BO3), benzoic acid, potassium phosphate, and/or sodium phosphate] 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 | 30382903649519 | GS1 | Shelfpack | 100 | In Commercial Distribution | |
| Primary | 50382903649513 | GS1 | ||||
| Unit of Use | 00382903649518 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K024240 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 4.00 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius