FDA.report

Medline

Primary DI
20193489188261
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
WCAA0084
Catalog number
WCAA0084
Device description
SKIRT GUARD, SBRFLA, K3
Published
2024-01-16
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
IMLARMREST, WHEELCHAIR

Product Code Classifications

CodeDeviceSpecialtyClass
IMLArmrest, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489188261PackageGS120In Commercial Distribution
10193489188264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019348918826120193489188261
1019348918826410193489188264

GMDN Terms

TermDefinition
Wheelchair armrestA small platform, typically cushioned, mounted on the lateral ends of a wheelchair to provide the user with a support on which to place the arms. The position of the platform (e.g., height) may be adjustable to suit the comfort and utility of the user.

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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40888277358462MEDLINEMPHPN318MPHPN3182026-03-19
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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