FDA UDI
In Commercial Distribution
🇺🇸 United States
CareLiving Lancing Device
DI: 00383568100420
·
Model: Lancing Device
·
Care Living Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CareLiving Lancing Device
- Primary DI
- 00383568100420
- Version / Model
- Lancing Device
- Catalog Number
- 83568-1004-20
- Company Name
- Care Living Diagnostics Inc.
- Labeler DUNS
- 125354643
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-10
- Public Version
- 2
- Public Version Date
- 2024-04-26
- Public Version Status
- Update
- Public Device Record Key
- b2ce588c-dc21-4dbe-9523-bffe9aa905be
Device Description
With12 customizable depth settings, Compact design, highly portable and easy to use, helps to achieve tiny stings on the skin.The button device is quick and easy to use; the device captures enough blood to test on the diabetes monitor for accurate results.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | General, Plastic Surgery | 878.4850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37243 | Manual blood lancing device, reusable | A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00383568100420 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232330 | 000 |