DEVICE: ACCU-CHEK® Tender (05705244009080)
Device Identifier (DI) Information
ACCU-CHEK® Tender
04541391001
In Commercial Distribution
Unomedical A/S
04541391001
In Commercial Distribution
Unomedical A/S
Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FPA | Set, Administration, Intravascular |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Protect the product from excessive humidity, sunlight and heat. Store at room temperature |
Clinically Relevant Size
[?]Size Type Text |
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Length: 110 Centimeter |
Depth: 13 Millimeter |
Angle: 30 degree |
Device Record Status
eb6cf632-291a-4572-ab54-75aee6665321
March 29, 2018
2
September 15, 2016
March 29, 2018
2
September 15, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05705244009097 | 210 | 05705244009080 | In Commercial Distribution | Outer box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
05705244013131
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-280-7801
xx@xx.xx
xx@xx.xx