FDA.reportPublic FDA data

Guardian

Primary DI
00197344014647
Brand
Guardian
Company
MEDLINE INDUSTRIES, INC.
Model
WCAA0013
Catalog number
WCAA0013
Device description
ARMREST PAD, FULL LENGTH, VINYL, K CHAIR
Published
2024-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IMLARMREST, WHEELCHAIR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMLArmrest, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197344014647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197344014647001973440146471973440146470197344014647

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30197344020779MEDLINEDYND364951DYND3649512026-08-19
00080196549422MEDLINE486800PL486800PL2025-05-06
00197344024936MEDLINEMG5002MG50022024-03-13
00888277172015MEDLINESG310SG3102024-05-02
00888277327552MEDLINE486802PL486802PL2025-03-25
00888277327569MEDLINE486803PL486803PL2025-03-25
00888277327576MEDLINE486804PL486804PL2025-03-25
00888277415075MEDLINE486801PL486801PL2025-05-06
40080196294344MEDLINEMDR107003LMDR107003L2020-10-12
40080196320999MEDLINEMDR107002EMDR107002E2016-10-14
40080196321002MEDLINEMDR107003EMDR107003E2016-10-14
10889942000388NAMICDYNJCAPDYNJCAP2026-08-18
10889942000395NAMICDYNJCAPRDYNJCAPR2026-08-18
20197344158895MEDLINEMDT12080XLMDT12080XL2026-08-18
20197344158918MEDLINEMDT12081LMDT12081L2026-08-18
20197344158932MEDLINEMDT12083LMDT12083L2026-08-18
20197344158956MEDLINEMDT12083XLMDT12083XL2026-08-18
20197344158970MEDLINEMDT12084XLMDT12084XL2026-08-18
20197344158987MEDLINEMDT12085LMDT12085L2026-08-18
20197344159014MEDLINEMDT12086XLMDT12086XL2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841447115854Freedom Designs™ Recover Armrest PadsINVACARE CORPORATIONIML2025-10-27
00841447115861Freedom Designs™ Armrest Pads OnlyINVACARE CORPORATIONIML2025-10-27
00841447115922Freedom Designs™ Arm Trough with T-NutsINVACARE CORPORATIONIML2025-10-27
00841447115939Freedom Designs™ Arm Trough with Multi Axial HardwareINVACARE CORPORATIONIML2025-10-27
00815067013319ProbasicsDrive Devilbiss HealthcareIML2025-06-10
00197344014623MEDLINEMEDLINE INDUSTRIES, INC.IML2025-05-07
10197344033485MEDLINEMEDLINE INDUSTRIES, INC.IML2025-04-05
80197344033484MEDLINEMEDLINE INDUSTRIES, INC.IML2025-04-05
10193489188127MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
10193489188134MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
10193489188141MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
10193489188165MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
00197344014555MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
80197344014551MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
80193489188126MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
80193489188133MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
80193489188140MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
80193489188164MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
10193489187939MEDLINEMEDLINE INDUSTRIES, INC.IML2024-12-20
10193489187953MEDLINEMEDLINE INDUSTRIES, INC.IML2024-12-20
10193489187960MEDLINEMEDLINE INDUSTRIES, INC.IML2024-12-20
00810113576909Vive MobilityVIVE HEALTH LLCIML2024-09-04
10810113576906Vive MobilityVIVE HEALTH LLCIML2024-09-04
00841447114949KIT ARMPAD FULL W/2 SCREWS CLRINVACARE CORPORATIONIML2024-07-25
00841447114956KIT ARMPAD DESK W/2 SCREWS CLRINVACARE CORPORATIONIML2024-07-25
10197344033478MEDLINEMEDLINE INDUSTRIES, INC.IML2024-06-20
00197344014562MedlineMEDLINE INDUSTRIES, INC.IML2024-04-11
10193489188264MedlineMEDLINE INDUSTRIES, INC.IML2024-01-16
20193489188261MedlineMEDLINE INDUSTRIES, INC.IML2024-01-16
10193489187946GuardianMEDLINE INDUSTRIES, INC.IML2023-12-21