FDA UDI
In Commercial Distribution
🇺🇸 United States
ACCU-CHEK® TenderLink
DI: 05705244004955
·
Model: 04925718001
·
Unomedical A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Basic Information
- Brand Name
- ACCU-CHEK® TenderLink
- Primary DI
- 05705244004955
- Version / Model
- 04925718001
- Company Name
- Unomedical A/S
- Labeler DUNS
- 306032491
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 3982aad0-bf4a-4670-94af-2a53c650779e
Device Description
Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
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
- No
- 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 |
|---|---|---|---|---|---|---|
| Primary | 05705244004955 | GS1 | ||||
| Unit of Use | 05705244009639 | GS1 | ||||
| Package | 05705244004962 | GS1 | Outer box | 112 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 80 | Centimeter | |
| Depth | 13 | Millimeter | |
| Angle | 30 | degree |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect the product from excessive humidity, sunlight and heat. Store at room temperature