FDA UDI
In Commercial Distribution
🇺🇸 United States
CareLiving Push Button Activated Safety lancet 28G
DI: 00383568100239
·
Model: Push Button Activated Safety Lancet 28
·
Care Living Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- CareLiving Push Button Activated Safety lancet 28G
- Primary DI
- 00383568100239
- Version / Model
- Push Button Activated Safety Lancet 28
- Catalog Number
- 83568-1002-39
- Company Name
- Care Living Diagnostics Inc.
- Labeler DUNS
- 125354643
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2024-01-25
- Public Version
- 1
- Public Version Date
- 2024-02-02
- Public Version Status
- New
- Public Device Record Key
- ae87e67b-79ad-4036-9764-9b5b30993d4a
Device Description
Push Button Activated Safety lancet 28G*1.6mm,100pcs Per Box,Sterile Singel-use,No need pre-loading,High speed of penetration and low puncture force provide users an almost painless experience of blood sampling.The Lancet is used for perpheral blood collection when clinical examination.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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
- Yes
- 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 | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | General, Plastic Surgery | 878.4850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61579 | Blood lancet, single-use | A sterile, hand-held, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider to manually puncture the skin of a patient to obtain a small blood specimen or drain a cyst or boil. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10383568100236 | GS1 | ||||
| Primary | 00383568100239 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 28 | Gauge |