DEVICE: Autosoft30™ (05705244004658)
Device Identifier (DI) Information
Autosoft30™
008009
Not in Commercial Distribution
Unomedical A/S
008009
Not in Commercial Distribution
Unomedical A/S
t:30 infusion set. 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.
|
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 from direct sunlight. Store at room temperature. |
Clinically Relevant Size
[?]Size Type Text |
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Length: 60 Centimeter |
Depth: 13 Millimeter |
Angle: 30 degree |
Device Record Status
2799e26f-dba7-4251-a497-c36fd6defe34
May 10, 2024
6
September 15, 2016
May 10, 2024
6
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 |
---|---|---|---|---|---|
05705244004665 | 48 | 05705244004658 | 2024-05-05 | Not 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:
05705244013520
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-877-801-6901
xx@xx.xx
xx@xx.xx