AccessGUDID - DEVICE: Thermoflect (30612899511201)

GUDID

Device Identifier (DI) Information

Brand Name: Thermoflect
Version or Model: 5110-200
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Encompass Group, L.L.C.

Primary DI Number: 30612899511201
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 121788819 *Terms of Use

Device Description: THERMOFLECT CAP, INFANT, 100EA TS THERMOFLECT BOUFFANT, STOCKINETTE, SILVER, 5/BG, 20 BG/CS

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:	No
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?
16219	Hypothermia-prevention cap	A head covering in the form of a cap intended to be worn by a patient typically during conditions of low body temperature and/or long surgical procedures to minimize loss of body heat from the head. It typically includes a heat-reflecting inner metal surface to facilitate retention of body heat. This is a single-use device.	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: b51a892d-206c-4c74-9d3b-91a65cd07a84
Public Version Date: May 05, 2023
Public Version Number: 2
DI Record Publish Date: October 27, 2022