FDA UDI
In Commercial Distribution
🇺🇸 United States
Easy Release
DI: 08809220580185
·
Model: SU303
·
SOOIL DEVELOPMENT CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Easy Release
- Primary DI
- 08809220580185
- Version / Model
- SU303
- Company Name
- SOOIL DEVELOPMENT CO.,LTD
- Labeler DUNS
- 688006266
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-11
- Public Version
- 5
- Public Version Date
- 2018-09-12
- Public Version Status
- Update
- Public Device Record Key
- 2a6a4209-409a-4d7f-a571-e79373764aa8
Device Description
Easy Release is an infusion set to connect to SOOIL's insulin reservoir for using insulin pump. It is inserted in the subcutaneous tissue and Not intended for use into blood vessel.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| LZG | Pump, Infusion, Insulin | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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 | 08809220580185 | GS1 | ||||
| Package | 08809220580550 | GS1 | Carton | 10 | In Commercial Distribution | |
| Package | 08809220580833 | GS1 | Carton | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K022317 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 6.4 | Gram | |
| Outer Diameter | 1.5 | Millimeter | |
| Needle Gauge | 27 | Gauge | |
| Length | 100 | Millimeter |