AccessGUDID - DEVICE: Medline (10193489002683)

GUDID

Device Identifier (DI) Information

Brand Name: Medline
Version or Model: MDS600SQ2R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MDS600SQ2R
Company Name: MEDLINE INDUSTRIES, INC.

Primary DI Number: 10193489002683
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 025460908 *Terms of Use

Device Description: PUMP,REFURBISHED,DVT,SEQUENTIAL, GEN2

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:	Yes
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?
44785	Sequential venous compression system inflator	An electrically-powered device intended to be used for the noninvasive treatment and prevention of venous disorders/sequelae. As part of a compression system, the pump provides the connected stocking/sleeve/suit applied to the extremities with the necessary pressure to promote venous blood flow through its sequential inflation and deflation. Also referred to as a pump, it typically consists of a compressor with advanced control/timing mechanism, pressure limiting device, tubing, and connectors. 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.	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
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between 15 and 35 Degrees Celsius
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e55c65cd-4e93-428b-8da8-769a73076052
Public Version Date: September 19, 2024
Public Version Number: 2
DI Record Publish Date: August 04, 2022

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: +1(800)633-5463
Email: service@medline.com

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