AccessGUDID - DEVICE: Whitehall Thermalators (00645724004530)

GUDID

Device Identifier (DI) Information

Brand Name: Whitehall Thermalators
Version or Model: T4SEG26
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T-4-S-EG26
Company Name: Whitehall Manufacturing Co

Primary DI Number: 00645724004530
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008312423 *Terms of Use

Device Description: THERMALATOR, 4 PACK, STATIONARY, -EG26

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?
17526	Thermoplastic-moulding water bath	A mains electricity (AC-powered) water bath specifically designed for the warming/heating of mouldable plastic materials (thermoplastics) used to create body positioning and body fixation devices, splints, and orthotic devices. It will typically consist of a large water holder (pan) that is temperature-regulated from, e.g., room temperature to 100? Celsius, temperature controls, thermometer/thermostats, timer. Sheets or pre-cut pieces of thermoplastic materials are placed into the water with the temperature set according to the material specifications so that these become soft enough to mould to the required shape.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IRQ	Unit, Heating, Powered

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: 1c7499ce-5d93-422a-a05f-c9758ec45bfb
Public Version Date: May 09, 2019
Public Version Number: 1
DI Record Publish Date: May 01, 2019

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: No Unit of Use DI Numbers Found 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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: (800) 782-7706
Email: info@whitehallmfg.com

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