FDA UDI
In Commercial Distribution
🇺🇸 United States
Accu-Chek Softclix
DI: 00365702702820
·
Model: 09917764001
·
Roche Diagnostics Operations, Inc.
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Accu-Chek Softclix
- Primary DI
- 00365702702820
- Version / Model
- 09917764001
- Catalog Number
- 09917764001
- Company Name
- Roche Diagnostics Operations, Inc.
- Labeler DUNS
- 141608724
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-22
- Public Version
- 1
- Public Version Date
- 2023-03-30
- Public Version Status
- New
- Public Device Record Key
- 7b10ca07-feee-4a03-894c-5e84e3e507d3
Device Description
Accu-Chek Softclix Kit Canada
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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 |
|---|---|---|---|---|
| QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | 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 |
| 45142 | Blood lancing device tip | A sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10365702702827 | GS1 | 12 | In Commercial Distribution | ||
| Primary | 00365702702820 | GS1 |