AccessGUDID - DEVICE: Comfortline HI LO 230V, 50mm drain and pipe interrupter (07350016061674)

GUDID

Device Identifier (DI) Information

Brand Name: Comfortline HI LO 230V, 50mm drain and pipe interrupter
Version or Model: 05194006
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Tr Equipment AB

Primary DI Number: 07350016061674
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 354437485 *Terms of Use

Device Description: Comfortline HI LO 230V, 50mm drain and pipe interrupter

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:	No
Prescription Use (Rx):	No
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?
14450	Hydrotherapy bath/tank	A bathtub or tank designed to be filled with warm water and occupied by a patient for the application of various forms of physical hydrotherapy such as water jet massage or aquatic exercise, typically to help treat musculoskeletal pain and stiffness or for physical rehabilitation; it is not dedicated to flotation therapy. It may have built-in water jet nozzles or an external heating/pump system to heat and circulate the water (whirlpool effect). This device is intended to be used in a healthcare facility.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KTC	Bath, Sitz, Nonpowered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 02b1b72d-30bc-410b-bbac-ceb8f772b9ff
Public Version Date: December 20, 2023
Public Version Number: 1
DI Record Publish Date: December 12, 2023