FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MiniCollect
DI: 29120017578554
·
Model: 450474
·
Greiner Bio-One GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- MiniCollect
- Primary DI
- 29120017578554
- Version / Model
- 450474
- Catalog Number
- 450474
- 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
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2022-05-02
- Public Version Status
- Update
- Public Device Record Key
- 4874665a-e978-44e9-a3b6-d92b2c8814a1
- Distribution End Date
- 2022-04-29
Device Description
MiniCollect® TUBE 1 ml K3E K3EDTA lavender cap, with cross cut, Spray-dried
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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JKA | Tubes, vials, systems, serum separators, blood collection | Clinical Chemistry | 862.1675 | 2 |
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 | 39120017578551 | GS1 | 10 | Not in Commercial Distribution | 2022-04-29 | |
| Primary | 29120017578554 | GS1 | ||||
| Unit of Use | 19120017578557 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K982999 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius