4 chamber sleeve

GUDID 18809802640433

STRETCHING MAT 4 1ea [One Set Box]

DAESUNG MAREF CO.,LTD.

Intermittent venous compression system
Primary Device ID18809802640433
NIH Device Record Key0bc7a933-8315-4992-a0aa-194847f50a99
Commercial Distribution StatusIn Commercial Distribution
Brand Name4 chamber sleeve
Version Model Number4MDRF00
Company DUNS688817949
Company NameDAESUNG MAREF CO.,LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809802640436 [Primary]
GS118809802640433 [Package]
Contains: 08809802640436
Package: Box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IRPMassager, Powered Inflatable Tube

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-27
Device Publish Date2021-12-17

On-Brand Devices [4 chamber sleeve]

18809802640617OVERLAPPING ARM SLEEVE Large 1ea [One polybag]
18809802640600OVERLAPPING ARM SLEEVE Medium 1ea [One polybag]
18809802640594OVERLAPPING HALF-LEG SLEEVE Medium Wide 1ea [One polybag]
18809802640587OVERLAPPING HALF-LEG SLEEVE Medium 1ea [One polybag]
18809802640570OVERLAPPING LEG SLEEVE Large Wide 1ea [One polybag]
18809802640563OVERLAPPING LEG SLEEVE Large 1ea [One polybag]
18809802640556OVERLAPPING LEG SLEEVE Medium X-Wide 1ea [One polybag]
18809802640549OVERLAPPING LEG SLEEVE Medium Wide 1ea [One polybag]
18809802640532OVERLAPPING LEG SLEEVE Medium 1ea [One polybag]
18809802640525OVERLAPPING LEG SLEEVE Small X-Wide 1ea [One polybag]
18809802640518OVERLAPPING LEG SLEEVE Small Wide 1ea [One polybag]
18809802640501OVERLAPPING LEG SLEEVE Small 1ea [One polybag]
18809802640495OVERLAPPING ARM CHEST 1ea, Strap 10*40 2ea, 5*40 1ea, 10*80 2ea, 5*80 1ea [One Set Box]
18809802640433STRETCHING MAT 4 1ea [One Set Box]
18809802640426CENTER BODY SLEEVE 1ea [One polybag]
18809802640419WAIST SLEEVE 1ea [One polybag]
18809802640396LEG SLEEVE XXLarge 1ea [One polybag]
18809802640389LEG SLEEVE XLarge 1ea [One polybag]
18809802640372LEG SLEEVE Large 1ea [One polybag]
18809802640402ARM SLEEVE 1ea [One polybag]
08809802640368LEG SLEEVE Large 2ea, LEG SLEEVE XLarge 2ea, LEG SLEEVE XXLarge 2ea, ARM SLEEVE 1ea, WAIST SLEEV

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