FDA UDI
In Commercial Distribution
🇺🇸 United States
FreeStyle
DI: 00357599000660
·
Model: 71582
·
ABBOTT DIABETES CARE INC
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- FreeStyle
- Primary DI
- 00357599000660
- Version / Model
- 71582
- Catalog Number
- 71582
- Company Name
- ABBOTT DIABETES CARE INC
- Labeler DUNS
- 966390890
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-28
- Public Version
- 3
- Public Version Date
- 2022-11-22
- Public Version Status
- Update
- Public Device Record Key
- 4170c61b-6922-4b0f-8409-e96e1e73a8b9
Device Description
FreeStyle Lancing Device II
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
| 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 |
|---|---|---|---|---|---|---|
| Package | 30357599000661 | GS1 | Case | 100 | In Commercial Distribution | |
| Primary | 00357599000660 | GS1 |
Customer Contacts
- Phone
- +1(888)522-5226
- [email protected]