FDA.reportPublic FDA data

AZMED

Primary DI
06973712280050
Brand
AZMED
Company
Hengshui Tianjian Medical Supplies CO.,LTD
Model
Black
Published
2024-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISRBand Or Belt, Pelvic Support

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISRBand Or Belt, Pelvic SupportPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973712280050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973712280050069737122800506973712280050

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal binder, reusableA strip, roll or tube of fabric or polymer material intended to be applied to the abdomen to support relaxed abdominal walls (e.g., after surgery, during pregnancy) or to provide support for another device (e.g., dressing, ultrasound transducer, percutaneous lead). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529951803
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973712280395HSYS2026-03-27
06973712280401HSYM2026-03-27
06973712280418HSYL2026-03-27
06973712280425HSYXL2026-03-27
06973712280388Elite Briteuniversal 2024-11-29
06973712280104ELITE BRITEXL2024-06-03
06973712280111ELITE BRITEuniversal 2024-06-03
06973712280128ELITE BRITEuniversal 2024-06-03
06973712280135ELITE BRITEAdult universal 2024-06-03
06973712280142ELITE BRITEChild universal 2024-06-03
06973712280159ELITE BRITES Left2024-06-03
06973712280166ELITE BRITEM Left2024-06-03
06973712280173ELITE BRITEL Left2024-06-03
06973712280180ELITE BRITEXL Left2024-06-03
06973712280197ELITE BRITES Right2024-06-03
06973712280203ELITE BRITEM Right2024-06-03
06973712280210ELITE BRITEL Right2024-06-03
06973712280227ELITE BRITEXL Right2024-06-03
06973712280234ELITE BRITES Left2024-06-03
06973712280241ELITE BRITEM Left2024-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04719879641868ComfyHealthComfy Health Group Co., Ltd.ISR2025-07-10
04719879641875ComfyHealthComfy Health Group Co., Ltd.ISR2025-07-10
04719879644562ComfyHealthComfy Health Group Co., Ltd.ISR2025-07-10
00819567011233ComfytopiaComfytopia, Inc.ISR2025-07-09
00819567016818ComfytopiaComfytopia, Inc.ISR2025-07-09
00810113579122ViveVIVE HEALTH LLCISR2025-05-20
00810113579139ViveVIVE HEALTH LLCISR2025-05-20
00810113579146ViveVIVE HEALTH LLCISR2025-05-20
00810113579153ViveVIVE HEALTH LLCISR2025-05-20
10810113579129ViveVIVE HEALTH LLCISR2025-05-20
10810113579136ViveVIVE HEALTH LLCISR2025-05-20
10810113579143ViveVIVE HEALTH LLCISR2025-05-20
10810113579150ViveVIVE HEALTH LLCISR2025-05-20
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00810041981158CoreTechVIVE HEALTH LLCISR2024-09-06
10810041981155CoreTechVIVE HEALTH LLCISR2024-09-06
06973712280043AZMEDHengshui Tianjian Medical Supplies CO.,LTDISR2024-03-27
10326053118514Regard™Resource Optimization & Innovation, L.L.C.ISR2023-08-10
20326053118511Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.ISR2023-08-10
00840252901881Therafit BeltsTherafin CorporationISR2023-07-06
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00840252901904Therafit BeltsTherafin CorporationISR2023-07-06
00840252902062Therafit BeltsTherafin CorporationISR2023-07-06
00840252902079Therafit BeltsTherafin CorporationISR2023-07-06
00840252902086Therafit BeltsTherafin CorporationISR2023-07-06
00840252902093Therafit BeltsTherafin CorporationISR2023-07-06
00840252902116Therafit BeltsTherafin CorporationISR2023-07-06
10810041980295CoreTechVIVE HEALTH LLCISR2023-06-15