FDA.report

MEDLINE

Primary DI
00197344029795
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
WCAA0127
Catalog number
WCAA0127
Device description
UPHOLSTERY, BACK F/16" KR SERIES
Published
2024-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KNNCOMPONENTS, WHEELCHAIR

Product Code Classifications

CodeDeviceSpecialtyClass
KNNComponents, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00197344029795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00197344029795001973440297951973440297950197344029795

GMDN Terms

TermDefinition
Wheelchair back restA padded support (typically vinyl covered) designed to attach to the back of a wheelchair. It typically replaces the wheelchair's sling upholstery and provides the wheelchair occupant with improved back support, posture, air circulation, and comfort.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
025460908
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
true
Sterilization required before use
false

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20197344009807HUDSON RCIHUD2417HUD24172026-03-19
20080196286789MEDLINEMDT2168282MDT21682822016-10-14
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20884389108229MEDLINENONLV200XXLNONLV200XXL2025-05-27
20884389155360MEDLINENONLV240NONLV2402025-05-27
20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
20888277336893MEDLINENON50240NON502402025-05-27

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