FDA.report

Wright

Primary DI
04042809581744
Brand
Wright
Company
WRIGHT THERAPY PRODUCTS, INC.
Model
A-105SMR
Device description
WRIGHT 667 FULL LEG SMALL REG
Published
2017-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JOWSLEEVE, LIMB, COMPRESSIBLE

Product Code Classifications

CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04042809581744PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04042809581744040428095817444042809581744

GMDN Terms

TermDefinition
Sequential venous compression system inflatorAn 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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)537-1063BSN.ORDERS@BSNMEDICAL.COM

Regulatory Flags

DUNS number
112742226
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04042809580112WrightA-1032017-03-24
04042809580129WrightA-103AK2017-03-24
04042809580136WrightA-103BK2017-03-24
04042809580143WrightA-104BK2017-03-24
04042809580150WrightA-105C2017-03-24
04042809580167WrightA-104C2017-03-24
04042809580174WrightA-104L2017-03-24
04042809580181WrightA-105FSD2017-03-24
04042809580198WrightA-3072017-03-24
04042809581652WrightP-W512017-03-24
04042809581669WrightP-W51-R2017-03-24
04042809581676WrightP-W52-D2017-03-24
04042809581683WrightP-W522017-03-24
04042809581690WrightA-105ML2017-03-24
04042809581706WrightA-105MR2017-03-24
04042809581713WrightA-105MS2017-03-24
04042809581720WrightA-105SL2017-03-24
04042809581737WrightA-105SML2017-03-24
04042809581751WrightA-105SMS2017-03-24
04042809581768WrightA-105SR2017-03-24

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