FDA UDI
In Commercial Distribution
🇺🇸 United States
MiniCollect
DI: 29120017578462
·
Model: 450419
·
Greiner Bio-One GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- MiniCollect
- Primary DI
- 29120017578462
- Version / Model
- 450419
- Catalog Number
- 450419
- Company Name
- Greiner Bio-One GmbH
- Labeler DUNS
- 303639066
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2020-09-22
- Public Version
- 2
- Public Version Date
- 2021-05-10
- Public Version Status
- Update
- Public Device Record Key
- 39b5633b-4b83-487a-b8b5-1b96971f2727
Device Description
MiniCollect® Carrier Tube amber, for bilirubin, 13x75
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 |
|---|---|---|---|---|
| FMH | CONTAINER, SPECIMEN, STERILE | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58149 | Capillary blood collection funnel IVD | An adaptor/attachment intended to be connected to a non-evacuated blood collection tube (e.g., it may pierce the tube stopper) to assist with the collection of blood droplets from the surface of skin during a manual or pump-assisted capillary blood collection procedure. When the required volume of blood has been collected and channelled into the blood collection tube, the funnel adaptor is removed. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 39120017578469 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 29120017578462 | GS1 | ||||
| Unit of Use | 19120017578465 | GS1 |