FDA.report

Medline

Primary DI
20080196414359
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDS630SSQ2
Catalog number
MDS630SSQ2
Device description
DBD-GARMENT,MEDLINE,DVT,SQ,THIGH,S,NO TR
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JOWSLEEVE, LIMB, COMPRESSIBLE

Product Code Classifications

CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20080196414359PackageGS110In Commercial Distribution
10080196414352PrimaryGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorConversion note
2008019641435914200801964143592Indicator 2 usually represents packaging or variable measure; UPC/EAN conversion is not shown.
1008019641435214100801964143521Indicator 1 usually represents packaging or variable measure; UPC/EAN conversion is not shown.

GMDN Terms

TermDefinition
Single-chamber venous compression system garment, single-useAn inflatable device in the form of a stocking, sleeve, or suit intended to be applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the intermittent inflation of a single-chamber. 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. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
false

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20080196286789MEDLINEMDT2168282MDT21682822016-10-14
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