FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Vacuette
DI: 29120049208641
·
Model: 456163
·
Greiner Bio-One GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- Vacuette
- Primary DI
- 29120049208641
- Version / Model
- 456163
- Catalog Number
- 456163
- Company Name
- Greiner Bio-One GmbH
- Labeler DUNS
- 303639066
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2021-01-14
- Public Version
- 4
- Public Version Date
- 2022-12-08
- Public Version Status
- Update
- Public Device Record Key
- a504df9b-dfdb-4bb3-bf64-50b5b9584a88
- Distribution End Date
- 2022-05-27
Device Description
VACUETTE® 2 ml Virus Stabilization Tube 13x100 red cap-white ring, PREMIUM, USA
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JSG | CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL | Microbiology | 866.2300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57927 | General tissue specimen container IVD, fixative/saline | A covered receptacle (single- or multiple-compartment) containing a tissue fixation or preservation solution [e.g., formalin, saline] intended to be used for the collection, and preservation and/or transport, of any type of tissue specimen (e.g., biopsy tissue) collected from any body part for in vitro diagnostic investigation. It does not contain patient-contact tissue specimen sampling/excision devices. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 39120049208648 | GS1 | 24 | Not in Commercial Distribution | 2022-05-27 | |
| Primary | 29120049208641 | GS1 | ||||
| Unit of Use | 19120049208644 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius