FDA UDI
In Commercial Distribution
🇺🇸 United States
Soft-Release-O
DI: 07613117010522
·
Model: S8061
·
Ypsomed AG
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- Soft-Release-O
- Primary DI
- 07613117010522
- Version / Model
- S8061
- Catalog Number
- S8061
- Company Name
- Ypsomed AG
- Labeler DUNS
- 481742760
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 4e6ab945-1cc2-44a7-a078-e5715c32ab64
Device Description
Soft-Release-O Infusion Set, 6 mm soft cannula, 80 cm (31") blue tubing. Infusion set with a soft cannula designed to work with the DANA DIABECARE insulin pump.
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 |
|---|---|---|---|---|
| FPA | Set, administration, intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35833 | Electric infusion pump administration set, single-use | A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07613117010539 | GS1 | SHIPPER BOX | 10 | In Commercial Distribution | |
| Primary | 07613117010522 | GS1 | ||||
| Unit of Use | 07613117017385 | GS1 |
Customer Contacts
- Phone
- +1(866)747-6645
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 6.0 | Millimeter |