SunWrap Mini 12 Arm Wrap Extra Large SWMAXL

GUDID 00856525007488

SunWrap™ Compression System provides localized compression and visualization through a central transparent bladder covering the dressed site. SunWrap™ Compression systems provides localized compression and visualization to manage access site bleeding post-hemodialysis or any covered wound that would require compression to control bleeding.

SUN SCIENTIFIC, INC.

Compression/pressure tubular garment
Primary Device ID00856525007488
NIH Device Record Keyfa13cdae-f5c6-466a-9ccb-87d89cb7fd14
Commercial Distribution Discontinuation2030-02-22
Commercial Distribution StatusIn Commercial Distribution
Brand NameSunWrap Mini 12 Arm Wrap Extra Large
Version Model NumberAW4050
Catalog NumberSWMAXL
Company DUNS609397224
Company NameSUN SCIENTIFIC, INC.
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone914.479-5108
Emailaalward@sun-scientific.com
Phone914.479-5108
Emailaalward@sun-scientific.com
Phone914.479-5108
Emailaalward@sun-scientific.com
Phone914.479-5108
Emailaalward@sun-scientific.com
Phone914.479-5108
Emailaalward@sun-scientific.com
Phone914.479-5108
Emailaalward@sun-scientific.com
Phone914.479-5108
Emailaalward@sun-scientific.com
Phone914.479-5108
Emailaalward@sun-scientific.com
Phone914.479-5108
Emailaalward@sun-scientific.com
Phone914.479-5108
Emailaalward@sun-scientific.com
Phone914.479-5108
Emailaalward@sun-scientific.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100856525007488 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHWDressing, Compression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-09
Device Publish Date2022-04-29

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