FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MiniCollect
DI: 29120017571005
·
Model: 450434
·
Greiner Bio-One GmbH
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
100
Basic Information
- Brand Name
- MiniCollect
- Primary DI
- 29120017571005
- Version / Model
- 450434
- Catalog Number
- 450434
- Company Name
- Greiner Bio-One GmbH
- Labeler DUNS
- 303639066
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2020-09-23
- Public Version
- 2
- Public Version Date
- 2024-01-03
- Public Version Status
- Update
- Public Device Record Key
- cc76e109-3eaa-4933-8940-2bfc1e76d8e8
- Distribution End Date
- 2024-01-03
Device Description
MiniCollect® Capillary for EDTA, 80 µL
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GIO | TUBE, COLLECTION, CAPILLARY BLOOD | Hematology | 864.6150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58154 | Capillary blood transfer tube IVD, EDTA | A non-sterile glass or plastic capillary blood transfer tube coated internally with the anticoagulant ethylenediaminetetraacetic acid (EDTA), and intended to be attached to a non-evacuated blood collection tube to assist with the transfer of blood drops from the blood collection site into the collection tube using a capillary action. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 49120017571009 | GS1 | 10 | Not in Commercial Distribution | 2024-01-03 | |
| Package | 39120017571002 | GS1 | 10 | Not in Commercial Distribution | 2024-01-03 | |
| Primary | 29120017571005 | GS1 | ||||
| Unit of Use | 19120017571008 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius