AccessGUDID - DEVICE: thalaset™ (05705244001411)

GUDID

Device Identifier (DI) Information

Brand Name: thalaset™
Version or Model: 71-080-2931
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Unomedical A/S

Primary DI Number: 05705244001411
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: Protect from direct sunlight. Store at room temperature

Clinically Relevant Size

[?]

Size Type Text
Length: 80 Centimeter
Depth: 10 Millimeter
Angle: 90 degree

Device Record Status

Public Device Record Key: 58462b97-1f41-48f9-97b5-b1313519d29e
Public Version Date: August 19, 2020
Public Version Number: 3
DI Record Publish Date: September 15, 2016