AccessGUDID - DEVICE: BluFlex (04719873230013)

GUDID

Device Identifier (DI) Information

Brand Name: BluFlex
Version or Model: BLU640CS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: PEGASUS MEDICAL SUPPLY, INC.

Primary DI Number: 04719873230013
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 656766271 *Terms of Use

Device Description: Intermittent venous compression system (Sleeves)

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
10969	Intermittent venous compression system	A system used for the noninvasive treatment and prevention of venous disorders and sequelae such as oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE). It functions by intermittently applying pressure to a patient's arms or legs to promote venous blood flow at timed intervals. This is achieved through the cyclical inflation and deflation of a single-chambered stocking, sleeve, or suit applied to the extremities. The system typically consists of a compression pump, control and timing mechanism, tubing, and pneumatic stocking(s) or suit.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOW	Sleeve, Limb, Compressible

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 2e6f8c1b-1d5f-42f2-9bf9-cc17d0190ece
Public Version Date: December 31, 2021
Public Version Number: 3
DI Record Publish Date: July 19, 2017