FDA UDI
In Commercial Distribution
🇺🇸 United States
DANA Diabecare
DI: 08809220584855
·
Model: 1
·
SOOIL DEVELOPMENT CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DANA Diabecare
- Primary DI
- 08809220584855
- Version / Model
- 1
- Company Name
- SOOIL DEVELOPMENT CO.,LTD
- Labeler DUNS
- 688006266
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-09
- Public Version
- 1
- Public Version Date
- 2023-06-19
- Public Version Status
- New
- Public Device Record Key
- 97f0d64d-25c6-4b92-ab88-c07161ddaa32
Device Description
DANA Diabecare is external programmable syringe infusion pump used for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. The pump is not intended for use with blood or blood products.
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| LZG | Pump, Infusion, Insulin | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64889 | Ambulatory insulin infusion pump, electronic, non-software-dosing | A portable electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus; it does not include insulin dosage determining software. It may be badge-like, designed to adhere to skin or clothing (e.g., with a pressure-sensitive adhesive), or worn in a case attached to the belt or carried in a pocket. It includes a reservoir (e.g., a cartridge similar to a syringe), a pumping mechanism, and an infusion-rate controller. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809220584855 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K063126 | 000 |