AccessGUDID - DEVICE: Maxi-Therm® Lite Headwrap (20613031826002)

GUDID

Device Identifier (DI) Information

Brand Name: Maxi-Therm® Lite Headwrap
Version or Model: 600
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 82600
Company Name: Gentherm Medical, LLC

Primary DI Number: 20613031826002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 004249462 *Terms of Use

Device Description: Thermal Regulating System

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":	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?
61251	External circulating-fluid core temperature regulation system pad, single-use	An underlay, overlay, or wrap(s) through which temperature-regulated fluid is circulated, as part of an external circulating-fluid core temperature regulation system, intended to elevate and/or lower a patient’s core body temperature, typically in the operating room (OR), intensive care unit (ICU), or a recovery unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). It is intended to be used by a healthcare professional in a clinical setting. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWJ	System, Thermal Regulating

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
Storage Environment Temperature: between -40 and 122 Degrees Fahrenheit
Storage Environment Temperature: between -40 and 50 Degrees Celsius
Storage Environment Humidity: between 20 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 59 and 86 Degrees Fahrenheit
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Humidity: between 20 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Width: 24.5 Inch
Length: 16.5 Inch
Weight: 0.34 Pound

Device Record Status

Public Device Record Key: cb6cdd27-8d96-4296-92c8-0e22c132c0c5
Public Version Date: December 18, 2023
Public Version Number: 4
DI Record Publish Date: August 30, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 10613031826005 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-800-989-7373
Email: csz@genthermcsz.com

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