AccessGUDID - DEVICE: Pretika (00813859002749)

GUDID

Device Identifier (DI) Information

Brand Name: Pretika
Version or Model: HA274
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HA274
Company Name: PRETIKA CORPORATION

Primary DI Number: 00813859002749
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 848304379 *Terms of Use

Device Description: Pretika Thermal Control Foot Massager

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
34663	Pneumatic massager, home-use	An pneumatically-powered massager designed for home-use only. It typically has a vibrating head or other feature which may be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head, or pads, may be interchangeable with others of different size and shape.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
ISA	Massager, therapeutic, electric

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: 540901de-258a-437e-9992-c3918f6f033a
Public Version Date: May 08, 2020
Public Version Number: 1
DI Record Publish Date: April 30, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10813859002746	2	00813859002749		In Commercial Distribution	Box
20813859002743	3	10813859002746		In Commercial Distribution	Master Carton

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: Yes
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(949)488-8818 ext: 101
Email: thomasnichols@pretika.com

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