FDA UDI
In Commercial Distribution
🇺🇸 United States
CareLiving Safety lancet 28G
DI: 00383568100215
·
Model: Safety Lancet 28
·
Care Living Diagnostics Inc.
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CareLiving Safety lancet 28G
- Primary DI
- 00383568100215
- Version / Model
- Safety Lancet 28
- Catalog Number
- 83568-1002-15
- Company Name
- Care Living Diagnostics Inc.
- Labeler DUNS
- 125354643
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-10
- Public Version
- 1
- Public Version Date
- 2023-11-20
- Public Version Status
- New
- Public Device Record Key
- 7955009b-6db2-4874-bca9-0b03ec2f8b8d
Device Description
Safety lancet 28G*1.8mm,100 Sterile Tip Lancets Per Box,One Handed Use,No Lancing Device Required,Automic Needle Retraction,Lock out after use is a Safety Feature That Negates Needle stick injuries And Prevents Blood cross-contamination
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
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 | 10383568100212 | GS1 | Case | 100 | Not in Commercial Distribution | 2023-11-17 |
| Primary | 00383568100215 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 28 | Gauge |