FDA UDI
In Commercial Distribution
🇺🇸 United States
BD MiniDraw™ SST™ Capillary Blood Collection Tube
DI: 50382903666046
·
Model: 366604
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
36
Basic Information
- Brand Name
- BD MiniDraw™ SST™ Capillary Blood Collection Tube
- Primary DI
- 50382903666046
- Version / Model
- 366604
- Catalog Number
- 366604
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 001292192
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 36
- Record Status
- Published
- Publish Date
- 2024-06-06
- Public Version
- 1
- Public Version Date
- 2024-06-14
- Public Version Status
- New
- Public Device Record Key
- 698fc299-316e-4463-b5f3-17419108297b
Device Description
BD MiniDraw™ SST™ Capillary Blood Collection Tube
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
- No
- 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 |
|---|---|---|---|---|
| 57892 | Capillary blood collection tube IVD, K2EDTA | A non-sterile glass or plastic collection tube containing the anticoagulant dipotassium ethylene diamine tetraacetic acid (K2EDTA), intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit). It is typically sealed at one or both ends with a putty-like substance following specimen collection, It is This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30382903666042 | GS1 | Shelfpack | 15 | In Commercial Distribution | |
| Primary | 50382903666046 | GS1 | ||||
| Unit of Use | 00382903666041 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230391 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius