FDA.reportPublic FDA data

JOBST Relax

Primary DI
04019702640885
Brand
JOBST Relax
Company
BSN-Jobst GmbH
Model
76096-00003-00
Device description
JOBST RELAX CCL1/THIGH HIGH/OPEN TOE/ZIPPER/ROSE
Published
2018-02-09
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDRBINDER, MEDICAL, THERAPEUTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDRBinder, Medical, TherapeuticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04019702640885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04019702640885040197026408854019702640885

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure sock/stocking, reusableA garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is normally available [non-prescription] over-the-counter (OTC) for use in the home and/or for hospitalized patients. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)537-1063BSN.ORDERS@BSNMEDICAL.COM

Regulatory Flags#

DUNS number
315917492
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04059993700806JOBST Elvarex Plus79541-00020-0079541-00020-002023-11-18
04059993444939JOBST Confidence73294-00686-0073294-00686-002023-05-02
04059993455676JOBST Confidence73295-00290-0073295-00290-002023-05-02
04059993456338JOBST Confidence73295-00298-0073295-00298-002023-05-02
04059993457564JOBST Confidence73295-00187-0073295-00187-002023-05-02
04059993478156JOBST Confidence73293-00038-0073293-00038-002023-05-02
04059993530618JOBST Confidence73316-00150-0073316-00150-002023-05-02
04059993538416JOBST Confidence73316-00346-0073316-00346-002023-05-02
04059993538607JOBST Confidence73316-00409-0073316-00409-002023-05-02
04059993538645JOBST Confidence73316-00413-0073316-00413-002023-05-02
04059993539499JOBST Confidence73316-00318-0073316-00318-002023-05-02
04059993540594JOBST Confidence73316-00564-0073316-00564-002023-05-02
04059993540730JOBST Confidence73316-00510-0073316-00510-002023-05-02
04059993541133JOBST Confidence73316-00438-0073316-00438-002023-05-02
04059993542109JOBST Confidence73205-00520-0073205-00520-002023-05-02
04059993543342JOBST Confidence73205-00420-0073205-00420-002023-05-02
04059993544677JOBST Confidence73205-00553-0073205-00553-002023-05-02
04059993552054JOBST Confidence73315-00378-0073315-00378-002023-05-02
04059993555406JOBST Confidence73205-00906-0073205-00906-002023-05-02
04059993555895JOBST Confidence73205-00955-0073205-00955-002023-05-02

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