FDA UDI
In Commercial Distribution
🇺🇸 United States
VACUETTE
DI: 29120126131015
·
Model: 455043P
·
Greiner Bio-One GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
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Basic Information
- Brand Name
- VACUETTE
- Primary DI
- 29120126131015
- Version / Model
- 455043P
- Catalog Number
- 455043P
- Company Name
- Greiner Bio-One GmbH
- Labeler DUNS
- 303639066
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2024-07-02
- Public Version
- 1
- Public Version Date
- 2024-07-10
- Public Version Status
- New
- Public Device Record Key
- 2a06647d-5185-4334-8af8-b25a29e1a44f
Device Description
VACUETTE® TUBE 8.5 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
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 |
|---|---|---|---|---|
| 41128 | Evacuated blood collection tube IVD, clot activator/separator | A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, 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 |
|---|---|---|---|---|---|---|
| Package | 39120126131012 | GS1 | 24 | In Commercial Distribution | ||
| Primary | 29120126131015 | GS1 | ||||
| Unit of Use | 19120126131018 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K960858 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius