AccessGUDID - DEVICE: POWER PLAY (04042809585759)

GUDID

Device Identifier (DI) Information

Brand Name: POWER PLAY
Version or Model: PPWR68U
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Compression Solutions, LLC

Primary DI Number: 04042809585759
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 879909877 *Terms of Use

Device Description: POWERPLAY WRIST - UNIVERSAL

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?
44768	Multi-chamber venous compression system garment, reusable	An inflatable device in the form of a stocking, sleeve, or suit that is applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the sequential inflation of several chambers. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IRP	MASSAGER, POWERED INFLATABLE TUBE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122154	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: babf5d75-553e-4278-8273-e6ec0dceb223
Public Version Date: August 08, 2024
Public Version Number: 5
DI Record Publish Date: April 04, 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: 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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)537-1063
Email: BSN.ORDERS@BSNMEDICAL.COM

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES