FDA.reportPublic FDA data

Compreflex Reduce Arm R3 Short BGE 2 CTN Liners

Primary DI
00745129338152
Brand
Compreflex Reduce Arm R3 Short BGE 2 CTN Liners
Company
SIGVARIS INC
Model
24AR
Catalog number
2413-ARS
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
2026-11-03
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDRBinder, Medical, Therapeutic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDRBinder, Medical, TherapeuticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00745129338152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00745129338152007451293381527451293381520745129338152

Device Sizes#

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

Contacts#

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

Regulatory Flags#

DUNS number
189738719
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00745129337971Compreflex Reduce Arm R1 Short BLK 2 CTN Liners24AR2401-ARS2026-11-03
00745129337988Compreflex Reduce Arm R1 Regular BLK 2 CTN Liners24AR2401-ARR2026-11-03
00745129337995Compreflex Reduce Arm R1 Long BLK 2 CTN Liners24AR2401-ARL2026-11-03
00745129338008Compreflex Reduce Arm R2 Short BLK 2 CTN Liners24AR2402-ARS2026-11-03
00745129338015Compreflex Reduce Arm R2 Regular BLK 2 CTN Liners24AR2402-ARR2026-11-03
00745129338022Compreflex Reduce Arm R2 Long BLK 2 CTN Liners24AR2402-ARL2026-11-03
00745129338039Compreflex Reduce Arm R3 Short BLK 2 CTN Liners24AR2403-ARS2026-11-03
00745129338046Compreflex Reduce Arm R3 Regular BLK 2 CTN Liners24AR2403-ARR2026-11-03
00745129338053Compreflex Reduce Arm R3 Long BLK 2 CTN Liners24AR2403-ARL2026-11-03
00745129338060Compreflex Reduce Arm R4 Short BLK 2 CTN Liners24AR2404-ARS2026-11-03
00745129338077Compreflex Reduce Arm R4 Regular BLK 2 CTN Liners24AR2404-ARR2026-11-03
00745129338084Compreflex Reduce Arm R4 Long BLK 2 CTN Liners24AR2404-ARL2026-11-03
00745129338091Compreflex Reduce Arm R1 Short BGE 2 CTN Liners24AR2411-ARS2026-11-03
00745129338107Compreflex Reduce Arm R1 Regular BGE 2 CTN Liners24AR2411-ARR2026-11-03
00745129338114Compreflex Reduce Arm R1 Long BGE 2 CTN Liners24AR2411-ARL2026-11-03
00745129338121Compreflex Reduce Arm R2 Short BGE 2 CTN Liners24AR2412-ARS2026-11-03
00745129338138Compreflex Reduce Arm R2 Regular BGE 2 CTN Liners24AR2412-ARR2026-11-03
00745129338145Compreflex Reduce Arm R2 Long BGE 2 CTN Liners24AR2412-ARL2026-11-03
00745129338169Compreflex Reduce Arm R3 Regular BGE 2 CTN Liners24AR2413-ARR2026-11-03
00745129338176Compreflex Reduce Arm R3 Long BGE 2 CTN Liners24AR2413-ARL2026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00745129337971Compreflex Reduce Arm R1 Short BLK 2 CTN LinersSIGVARIS INCMDR2026-11-03
00745129337988Compreflex Reduce Arm R1 Regular BLK 2 CTN LinersSIGVARIS INCMDR2026-11-03
00745129337995Compreflex Reduce Arm R1 Long BLK 2 CTN LinersSIGVARIS INCMDR2026-11-03
00745129338008Compreflex Reduce Arm R2 Short BLK 2 CTN LinersSIGVARIS INCMDR2026-11-03
00745129338015Compreflex Reduce Arm R2 Regular BLK 2 CTN LinersSIGVARIS INCMDR2026-11-03
00745129338022Compreflex Reduce Arm R2 Long BLK 2 CTN LinersSIGVARIS INCMDR2026-11-03
00745129338039Compreflex Reduce Arm R3 Short BLK 2 CTN LinersSIGVARIS INCMDR2026-11-03
00745129338046Compreflex Reduce Arm R3 Regular BLK 2 CTN LinersSIGVARIS INCMDR2026-11-03
00745129338053Compreflex Reduce Arm R3 Long BLK 2 CTN LinersSIGVARIS INCMDR2026-11-03
00745129338060Compreflex Reduce Arm R4 Short BLK 2 CTN LinersSIGVARIS INCMDR2026-11-03
00745129338077Compreflex Reduce Arm R4 Regular BLK 2 CTN LinersSIGVARIS INCMDR2026-11-03
00745129338084Compreflex Reduce Arm R4 Long BLK 2 CTN LinersSIGVARIS INCMDR2026-11-03
00745129338091Compreflex Reduce Arm R1 Short BGE 2 CTN LinersSIGVARIS INCMDR2026-11-03
00745129338107Compreflex Reduce Arm R1 Regular BGE 2 CTN LinersSIGVARIS INCMDR2026-11-03
00745129338114Compreflex Reduce Arm R1 Long BGE 2 CTN LinersSIGVARIS INCMDR2026-11-03
00745129338121Compreflex Reduce Arm R2 Short BGE 2 CTN LinersSIGVARIS INCMDR2026-11-03
00745129338138Compreflex Reduce Arm R2 Regular BGE 2 CTN LinersSIGVARIS INCMDR2026-11-03
00745129338145Compreflex Reduce Arm R2 Long BGE 2 CTN LinersSIGVARIS INCMDR2026-11-03
00745129338169Compreflex Reduce Arm R3 Regular BGE 2 CTN LinersSIGVARIS INCMDR2026-11-03
00745129338176Compreflex Reduce Arm R3 Long BGE 2 CTN LinersSIGVARIS INCMDR2026-11-03
00745129338183Compreflex Reduce Arm R4 Short BGE 2 CTN LinersSIGVARIS INCMDR2026-11-03
00745129338190Compreflex Reduce Arm R4 Regular BGE 2 CTN LinersSIGVARIS INCMDR2026-11-03
00745129338206Compreflex Reduce Arm R4 Long BGE 2 CTN LinersSIGVARIS INCMDR2026-11-03
00745129338213Compreflex Reduce Hand One Size BlackSIGVARIS INCMDR2026-11-03
00745129338220Compreflex Reduce Hand One Size BeigeSIGVARIS INCMDR2026-11-03
08300496073765SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
08300496073772SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
08300496073789SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
08300496073796SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
08300496073802SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16