FDA UDI
In Commercial Distribution
🇺🇸 United States
MiniCollect
DI: 29120017578905
·
Model: 450438
·
Greiner Bio-One GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
200
Basic Information
- Brand Name
- MiniCollect
- Primary DI
- 29120017578905
- Version / Model
- 450438
- Catalog Number
- 450438
- Company Name
- Greiner Bio-One GmbH
- Labeler DUNS
- 303639066
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2020-09-24
- Public Version
- 1
- Public Version Date
- 2020-10-02
- Public Version Status
- New
- Public Device Record Key
- 14b6cec1-9024-4ea8-b818-38e299efe22a
Device Description
MiniCollect® Safety Lancet 28G, penetration depth 1.25 mm lavender, for capillary blood collection, sterile with needle
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 |
|---|---|---|---|---|
| FMK | Lancet, blood | General, Plastic Surgery | 878.4850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61578 | Manual blood lancing device, single-use | A sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. It includes a preloaded lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 39120017578902 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 29120017578905 | GS1 | ||||
| Unit of Use | 19120017578908 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 36 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry