Identity
- Trade Name
- CareLiving Lancing Device+100 Lancets FDA UDI
- Generic Name
- Manual blood lancing device, reusable FDA UDI
- Device Name
- 1 x CARELIVING Lancing device, 100 x 30 Gauge Lancets.1 x User Guide,LESS PAINFUL,STRONG PENETRATION,12 OPTIONAL DEPTH SETTINGS,EASY-TO-USE LANCET INJECTOR FDA UDI
- Model / Reference
- Lancing Device+Lancets FDA UDI
- Description
- 1 x CARELIVING Lancing device, 100 x 30 Gauge Lancets.1 x User Guide,LESS PAINFUL,STRONG PENETRATION,12 OPTIONAL DEPTH SETTINGS,EASY-TO-USE LANCET INJECTOR FDA UDI
Identifiers
- Catalog Number
- 83568-1004-13 FDA UDI
- Primary DI / UDI-DI
- 00383568100413 FDA UDI
- 510(k) Number
- K232330 FDA UDI
- FDA Product Code
- QRL FDA UDIQRK FDA UDI
- GMDN Term
- Manual blood lancing device, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood lancet, single-useManual blood lancing device, reusable
CareLiving Lancing Device+100 Lancets by Care Living Diagnostics Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K232330 also covers:
- CareLiving Lancing Device — CARE LIVING DIAGNOSTICS INC
- Genteel — Ningbo Medsun Medical Co., Ltd.
- Genteel — Ningbo Medsun Medical Co., Ltd.
- MEDSUN — Ningbo Medsun Medical Co., Ltd.
- MEDSUN — Ningbo Medsun Medical Co., Ltd.
- MEDSUN — Ningbo Medsun Medical Co., Ltd.
- MEDSUN — Ningbo Medsun Medical Co., Ltd.
- MEDSUN — Ningbo Medsun Medical Co., Ltd.
- MEDSUN — Ningbo Medsun Medical Co., Ltd.
- MEDSUN — Ningbo Medsun Medical Co., Ltd.
- MEDSUN — Ningbo Medsun Medical Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Care Living Diagnostics Inc
Sources (1)
- FDA UDI f2c82c78-4f96-430a-b85b-3e6336d9e818 35 fields · synced Jun 8, 2026