FDA UDI
In Commercial Distribution
🇺🇸 United States
DANA Diabecare
DI: 08809220581045
·
Model: ⅡS Kits
·
SOOIL DEVELOPMENT CO.,LTD
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DANA Diabecare
- Primary DI
- 08809220581045
- Version / Model
- ⅡS Kits
- Company Name
- SOOIL DEVELOPMENT CO.,LTD
- Labeler DUNS
- 688006266
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-06
- Public Version
- 4
- Public Version Date
- 2018-09-12
- Public Version Status
- Update
- Public Device Record Key
- 30a0b81a-a6da-4ea0-98ae-09758637c029
Device Description
DANA Diabecare ⅡS is external programmable syringe infusion pump used for the subcutaneous delivery of insulin for the treatment of diabetes mellitus.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- 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 |
|---|---|---|---|---|
| MRZ | Accessories, Pump, Infusion | General Hospital | 880.5725 | 2 |
| LGZ | Warmer, Thermal, Infusion Fluid | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35838 | Ambulatory insulin infusion pump reservoir | An insulin-filled receptacle (e.g., a cartridge similar to a syringe) intended to be used together with a body-worn insulin pump for the delivery of patient-controlled amounts of insulin to an ambulatory diabetic. This is a single-use device. | No | Active |
| 35983 | Ambulatory insulin infusion pump, electronic | A portable, battery-powered, electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus. 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. The pump infuses microvolume pulses and/or bolus doses of insulin subcutaneously, typically into the abdomen, through a needle or catheter (not included). | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809220581045 | GS1 |