AccessGUDID - DEVICE: Replexa+ Device (00850886008009)

GUDID

Device Identifier (DI) Information

Brand Name: Replexa+ Device
Version or Model: C1416
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PROMEDTEK, INC.

Primary DI Number: 00850886008009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 604679527 *Terms of Use

Device Description: Replexa+ Model C1416 Shortwave Diathermy Device

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):	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?
34668	Short-wave diathermy treatment system, home-use	An assembly of devices designed to be operated by a patient in the home to provide therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio-frequency bands of 13 megahertz (MHz) to 27.12 MHz. It typically consists of an electric generator and two electrodes (active and return) intended to be held on/near the patient. This system is typically used to treat pain, muscle spasms, and joint contractures; it is not used for surgery or to treat malignancies.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IMJ	Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162240	000

Device Exempt from Premarket Submission: No 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: 5ad6fd6d-4b2f-44c1-be4a-8b9e6409dda5
Public Version Date: July 16, 2019
Public Version Number: 1
DI Record Publish Date: July 08, 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: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 8663882410
Email: info@promedtek.com

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