FDA UDI
In Commercial Distribution
🇺🇸 United States
VACUETTE
DI: 29120049200317
·
Model: 455243
·
Greiner Bio-One GmbH
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- VACUETTE
- Primary DI
- 29120049200317
- Version / Model
- 455243
- Catalog Number
- 455243
- Company Name
- Greiner Bio-One GmbH
- Labeler DUNS
- 303639066
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2017-04-27
- Public Version
- 4
- Public Version Date
- 2021-07-22
- Public Version Status
- Update
- Public Device Record Key
- 1ca9a583-cb55-4104-a548-4dd86fa3954c
Device Description
VACUETTE® TUBE 9 ml Urine CCM 16x100 yellow cap-black ring, Conical Base, 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
- Yes
- 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 |
|---|---|---|---|---|
| LIO | Device, specimen collection | Microbiology | 866.2900 | 1 |
| JSM | CULTURE MEDIA, NON-PROPAGATING TRANSPORT | Microbiology | 866.2390 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58151 | Evacuated urine specimen container IVD, preservative | A covered receptacle containing a pre-measured amount of vacuum and one or multiple preservatives [e.g., mercuric oxide, boric acid (H3BO3), benzoic acid, potassium phosphate, and/or sodium phosphate] intended to be used for the collection, and preservation and/or transport, of a urine specimen for culture, analysis, and/or other in vitro diagnostic investigation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 39120049200314 | GS1 | 24 | In Commercial Distribution | ||
| Primary | 29120049200317 | GS1 | ||||
| Unit of Use | 19120049200310 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius