FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Vacutainer® K2 EDTA (K2E) Plus Blood Collection Tubes
DI: 30382903666431
·
Model: 366643
·
Becton, Dickinson U.K. Limited
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
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Basic Information
- Brand Name
- BD Vacutainer® K2 EDTA (K2E) Plus Blood Collection Tubes
- Primary DI
- 30382903666431
- Version / Model
- 366643
- Catalog Number
- 366643
- 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
- 2016-07-28
- Public Version
- 7
- Public Version Date
- 2024-05-02
- Public Version Status
- Update
- Public Device Record Key
- e3d98245-746b-45e0-a5c2-29eec5a6405f
Device Description
TUBE EDTA PLH 16X100 10.0 SLBL USA LAV
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 |
|---|---|---|---|---|
| GIM | Tubes, vacuum sample, with anticoagulant | Clinical Chemistry | 862.1675 | 2 |
| JKA | Tubes, vials, systems, serum separators, blood collection | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47592 | Evacuated blood collection tube IVD, anticoagulant | A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and an anticoagulant [e.g., sodium heparin, sodium citrate, potassium oxalate, ethylenediaminetetraacetic acid (EDTA)]. 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 lead, toxicology, nutritional-chemistry, and other plasma 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 | 30382903666431 | GS1 | ||||
| Unit of Use | 00382903666430 | GS1 | ||||
| Package | 50382903666435 | GS1 | Case | 10 | In Commercial Distribution |
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius