FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Vacuette
DI: 29120017577656
·
Model: 458815
·
Greiner Bio-One GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
300
Basic Information
- Brand Name
- Vacuette
- Primary DI
- 29120017577656
- Version / Model
- 458815
- Catalog Number
- 458815
- Company Name
- Greiner Bio-One GmbH
- Labeler DUNS
- 303639066
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 300
- Record Status
- Published
- Publish Date
- 2020-09-24
- Public Version
- 3
- Public Version Date
- 2021-09-22
- Public Version Status
- Update
- Public Device Record Key
- 65198c1b-2f53-42e5-920b-90b99805bb86
- Distribution End Date
- 2021-09-21
Device Description
VacuDrop
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58146 | Blood/blood culture specimen transfer spike IVD | A blood or blood culture specimen transfer device intended to be used to obtain for analysis a specimen of blood, blood components (e.g., platelets), or blood culture from a specimen receptacle, and facilitate specimen transfer to another receptacle [e.g., evacuated blood collection tube]. It is a hand-held, manually-operated device with a spike/needle for sampling the specimen through the sealed stopper of the receptacle (i.e., without opening the receptacle), and is designed to reduce the risk of user exposure to the specimen and spike/needle [e.g., has a plastic housing for guarding the needle]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 39120017577653 | GS1 | 10 | Not in Commercial Distribution | 2021-09-21 | |
| Primary | 29120017577656 | GS1 | ||||
| Unit of Use | 19120017577659 | GS1 |