FDA.reportPublic FDA data

MEDLINE

Primary DI
00197344029955
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
WCAA0146
Catalog number
WCAA0146
Device description
AXLE&NUT.REARWHEEL.KR SERIES
Published
2024-06-20
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
KNNCOMPONENTS, WHEELCHAIR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNNComponents, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197344029955PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197344029955001973440299551973440299550197344029955

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair wheelA circular frame of metal and/or synthetic materials which turns on a central axle that is attached to the body of a wheelchair to enable the wheelchair to move when propelled. It comes in a variety of designs, diameters and weights, and is typically fitted with a tyre (tire); brackets for mounting the wheel onto the wheelchair may be included with the device.

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
10888277417205MEDLINEMSG9460MSG94602026-08-03
10888277417212MEDLINEMSG9465MSG94652026-08-03
10888277417229MEDLINEMSG9470MSG94702026-08-03
10888277417236MEDLINEMSG9475MSG94752026-08-03
10888277417243MEDLINEMSG9480MSG94802026-08-03
10888277417250MEDLINEMSG9485MSG94852026-08-03
10888277417267MEDLINEMSG9490MSG94902026-08-03
10888277603516MEDLINEMSG9590MSG95902026-08-03
20197344102898GeminiGEM3120CGEM3120C2024-08-02
20197344102904GeminiGEM3120SCGEM3120SC2024-07-15
10080196184125GeminiGEM3120SGEM3120S2016-10-14
10080196184286MEDLINEGEM3130SGEM3130S2016-10-14
10197344169405MEDLINEMSCSRG9636MSCSRG96362026-07-31
10198459678653MEDLINEURO175806PSURO175806PS2026-07-31
10198459678660MEDLINEURO175808PSURO175808PS2026-07-31
10198459678677MEDLINEURO175806SURO175806S2026-07-31
10198459678684MEDLINEURO175808SURO175808S2026-07-31
10198459678691MEDLINEURO175810SURO175810S2026-07-31
10198459679025MEDLINEURO175810PSURO175810PS2026-07-31
20197344219237MEDLINENON27393NON273932026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420082931091Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931107Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931114Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931121Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931138Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931145Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931152Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931169Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931176Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931183Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931190Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931206Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931213Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931220Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931237Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931244Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931251Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931268Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931275Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931282Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931299Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931305Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931312Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931329Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931336Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931343Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931350Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931367Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931374Spex LimitedSPEX LIMITEDKNN2026-07-31
09420082931381Spex LimitedSPEX LIMITEDKNN2026-07-31