FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Microtainer® SST™ - Amber
DI: 30382903659785
·
Model: 365978
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- BD Microtainer® SST™ - Amber
- Primary DI
- 30382903659785
- Version / Model
- 365978
- Catalog Number
- 365978
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 001292192
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-07-28
- Public Version
- 5
- Public Version Date
- 2024-02-26
- Public Version Status
- Update
- Public Device Record Key
- e2c7b696-9364-4e28-b6d7-6038308f4ce0
Device Description
TUBE MICRO W/MICROGARD SST GLD/AMB
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JKA | Tubes, vials, systems, serum separators, blood collection | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58138 | Non-evacuated blood collection tube IVD, clot activator/separator | A non-evacuated glass or plastic tube, sealed with a stopper, containing a clot activator and a separator (e.g., gel) to separate blood serum from cells. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., blood serum chemistry determinations). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30382903659785 | GS1 | ||||
| Unit of Use | 00382903659784 | GS1 | ||||
| Package | 50382903659789 | GS1 | Case | 4 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K991702 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 25 Degrees Celsius