AccessGUDID - DEVICE: contact detach (05705244025264)

GUDID

Device Identifier (DI) Information

Brand Name: contact detach
Version or Model: FG000016-03
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Unomedical A/S

Primary DI Number: 05705244025264
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 306032491 *Terms of Use

Device Description: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle

Clinically Relevant Size

[?]

Size Type Text
Angle: 90 degree
Depth: 6 Millimeter
Length: 60 Centimeter

Device Record Status

Public Device Record Key: 70da3a82-0d99-4962-9b44-832e67763d4a
Public Version Date: April 30, 2024
Public Version Number: 3
DI Record Publish Date: December 21, 2022