AccessGUDID - DEVICE: Thermoflect (30612899003812)

GUDID

Device Identifier (DI) Information

Brand Name: Thermoflect
Version or Model: 5190-600
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Encompass Group, L.L.C.

Primary DI Number: 30612899003812
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 121788819 *Terms of Use

Device Description: THERMOFLECT GOWN, S, 25EA TS THERMOFLECT PATIENT IV GOWN, SILVER/BLUE, 5/BG, 5BG/CS NW

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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":	Yes
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?
62340	Hypothermia-prevention whole-body suit	A full-body overall intended to be worn by a patient in a clinical setting to minimize loss of body heat when the patient experiences low body temperature and/or is under at-risk conditions for low body temperature (e.g., long surgical procedures). It is typically a multilayer or multi-laminate suit made of synthetic materials including a layer with heat-insulating properties to facilitate retention of body heat. This is a reusable device after appropriate cleaning.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FME	Gown, Examination

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: 1e6e4989-62ab-4fc5-a7ee-a2ef146c7e14
Public Version Date: May 05, 2023
Public Version Number: 2
DI Record Publish Date: November 01, 2022