Sun Wrap Forearm Left SW-FAL

GUDID 00856525007006

3.3. SunWrap™ Compression Sleeve are used to maintain pressure against a dressing covering following a dialysis treatment for the needle sites in conjunction with an inflation source to provide static pneumatic compression to aid in the prevention of bleeding.

SUN SCIENTIFIC, INC.

Compression/pressure tubular garment
Primary Device ID00856525007006
NIH Device Record Key9238d195-294f-4064-8025-3d673b22ad74
Commercial Distribution Discontinuation2025-02-22
Commercial Distribution StatusIn Commercial Distribution
Brand NameSun Wrap Forearm Left
Version Model NumberFA1160-01
Catalog NumberSW-FAL
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
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
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
GS100856525007006 [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 Date2021-03-02
Device Publish Date2021-02-22

Devices Manufactured by SUN SCIENTIFIC, INC.

00850051939565 - AeroWrap™ Full Leg2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
00850051939572 - AeroWrap™ Full Leg2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
00850051939589 - AeroWrap™ Full Leg2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
00850051939596 - AeroWrap™ Full Leg2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
00850051939602 - AeroWrap™ Full Leg2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
00850051939619 - AeroWrap™ Full Leg2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
00850051939626 - AeroWrap™ Full Leg2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
00850051939640 - AeroWrap™ Full Leg2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k

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