FDA.reportPublic FDA data

Chipsleeve Arm No Hand XXL Short RT

Primary DI
00745129334024
Brand
Chipsleeve Arm No Hand XXL Short RT
Company
SIGVARIS INC
Model
2635-ANS-R
Catalog number
2635-ANS-R
Device description
Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.
Published
2026-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMOBinder, Elastic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMOBinder, ElasticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00745129334024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00745129334024007451293340247451293340240745129334024

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose medical foam padding, single-useA roll, sheet or preformed shape of synthetic foam material [e.g., styrene-butadiene rubber (SBR)] intended to be applied to and/or compress a local area of the body for various preventative/therapeutic applications (e.g., in compression bandaging, padding under casts and splints, padding for anatomical depressions), typically over intact and healthy skin. It is intended for use in the home or a clinical setting. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)322-7744sigvariscares@sigvaris.com

Regulatory Flags#

DUNS number
189738719
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00745129313197CompreFLEXMS01MSC14012024-01-23
00745129313203CompreFLEXMS02MSC14022024-01-23
00745129313210CompreFLEXMS03MSC14032024-01-23
00745129313227CompreFLEXMS04MSC14042024-01-23
00745129313234CompreFLEXMS05MSC14052024-01-23
00745129313241CompreFLEXMS01MSC1401T2024-01-23
00745129313258CompreFLEXMS02MSC1402T2024-01-23
00745129313265CompreFLEXMS03MSC1403T2024-01-23
00745129313272CompreFLEXMS04MSC1404T2024-01-23
00745129313289CompreFLEXMS05MSC1405T2024-01-23
00745129313395CompreFLEXMS01MSC1401LINER2024-01-23
00745129313401CompreFLEXMS02MSC1402LINER2024-01-23
00745129313418CompreFLEXMS03MSC1403LINER2024-01-23
00745129313425CompreFLEXMS04MSC1404LINER2024-01-23
00745129313432CompreFLEXMS05MSC1405LINER2024-01-23
00745129335069Envelo Arm Wrap Small Short Beige3111-ARS or 221093111-ARS2026-07-22
00745129335076Envelo Arm Wrap Small Regular Beige3111-ARR or 221103111-ARR2026-07-22
00745129335083Envelo Arm Wrap Small Long Beige3111-ARL or 221113111-ARL2026-07-22
00745129335090Envelo Arm Wrap Max Small Short Beige3111-AMS or 221123111-AMS2026-07-22
00745129335106Envelo Arm Wrap Max Small Regular Beige3111-AMR or 221133111-AMR2026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00745129333737Chipsleeve Arm No Hand SM Long LT SIGVARIS INCKMO2026-01-09
00745129333744Chipsleeve Arm No Hand SM Long RT SIGVARIS INCKMO2026-01-09
00745129333751Chipsleeve Arm No Hand SM Reg LT SIGVARIS INCKMO2026-01-09
00745129333768Chipsleeve Arm No Hand SM Reg RT SIGVARIS INCKMO2026-01-09
00745129333775Chipsleeve Arm No Hand SM Short LT SIGVARIS INCKMO2026-01-09
00745129333782Chipsleeve Arm No Hand SM Short RT SIGVARIS INCKMO2026-01-09
00745129333799Chipsleeve Arm No Hand MD Long LT SIGVARIS INCKMO2026-01-09
00745129333805Chipsleeve Arm No Hand MD Long RT SIGVARIS INCKMO2026-01-09
00745129333812Chipsleeve Arm No Hand MD Reg LT SIGVARIS INCKMO2026-01-09
00745129333829Chipsleeve Arm No Hand MD Reg RT SIGVARIS INCKMO2026-01-09
00745129333836Chipsleeve Arm No Hand MD Short LT SIGVARIS INCKMO2026-01-09
00745129333843Chipsleeve Arm No Hand MD Short RT SIGVARIS INCKMO2026-01-09
00745129333850Chipsleeve Arm No Hand LG Long LT SIGVARIS INCKMO2026-01-09
00745129333867Chipsleeve Arm No Hand LG Long RT SIGVARIS INCKMO2026-01-09
00745129333874Chipsleeve Arm No Hand LG Reg LT SIGVARIS INCKMO2026-01-09
00745129333881Chipsleeve Arm No Hand LG Reg RT SIGVARIS INCKMO2026-01-09
00745129333898Chipsleeve Arm No Hand LG Short LT SIGVARIS INCKMO2026-01-09
00745129333904Chipsleeve Arm No Hand LG Short RT SIGVARIS INCKMO2026-01-09
00745129333911Chipsleeve Arm No Hand XL Long LT SIGVARIS INCKMO2026-01-09
00745129333928Chipsleeve Arm No Hand XL Long RT SIGVARIS INCKMO2026-01-09
00745129333935Chipsleeve Arm No Hand XL Reg LT SIGVARIS INCKMO2026-01-09
00745129333942Chipsleeve Arm No Hand XL Reg RTSIGVARIS INCKMO2026-01-09
00745129333959Chipsleeve Arm No Hand XL Short LT SIGVARIS INCKMO2026-01-09
00745129333966Chipsleeve Arm No Hand XL Short RT SIGVARIS INCKMO2026-01-09
00745129333973Chipsleeve Arm No Hand XXL Long LT SIGVARIS INCKMO2026-01-09
00745129333980Chipsleeve Arm No Hand XXL Long RT SIGVARIS INCKMO2026-01-09
00745129333997Chipsleeve Arm No Hand XXL Reg LT SIGVARIS INCKMO2026-01-09
00745129334000Chipsleeve Arm No Hand XXL Reg RT SIGVARIS INCKMO2026-01-09
00745129334017Chipsleeve Arm No Hand XXL Short LT SIGVARIS INCKMO2026-01-09
00636257078617MEDIMEDI MANUFACTURING, INC.KMO2024-10-29