AccessGUDID - DEVICE: Sharper Image (00843479186598)

GUDID

Device Identifier (DI) Information

Brand Name: Sharper Image
Version or Model: 1017472
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Merchsource, LLC

Primary DI Number: 00843479186598
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 121820737 *Terms of Use

Device Description: No description.

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?
47888	Portable sequential venous compression system	A compact portable system designed for the noninvasive treatment and prevention of venous disorders and sequelae (lymphatic, arterial, trauma) by facilitating better vascular flow, as well as minimizing venous stasis during/after surgery and immobilization. It applies sequential pressure to a patient's arm or leg to promote venous blood flow and typically consists of an electrically-powered compression pump, control/timing mechanism, rechargeable batteries, and tubing that connect to an integral cuff or pneumatic stockings that inflate and deflate sequentially. It is normally available [non-prescription] over-the-counter (OTC) for home-use and/or for hospitalized/institutionalized patients.	Active	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: d997dd34-2734-49a3-a719-e329b8bed5a1
Public Version Date: September 25, 2023
Public Version Number: 1
DI Record Publish Date: September 15, 2023

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: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 18003742744
Email: isupport@merchsource.com

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