FDA.report

GSO Medical

Primary DI
B504TQGDTC1230SS0
Brand
GSO Medical
Company
Provision
Model
GDTC1230SS
Published
2024-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KCYTourniquet, Pneumatic

Product Code Classifications

CodeDeviceSpecialtyClass
KCYTourniquet, PneumaticGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B504TQGDTC1230SS0PrimaryHIBCC0

GMDN Terms

TermDefinition
Emergency tourniquet, pneumaticAn inflatable cuff with fastening mechanism intended to be placed around a patient's limb (arm or leg) and pneumatically inflated from an integrated small gas cartridge to reduce and/or occlude blood circulation to the distal portion of the limb during an emergency situation. It is typically used by emergency medical services (EMS) for emergency blood loss prevention. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
541-480-7953customersupport@provisiondrs.com

Regulatory Flags

DUNS number
016889401
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B504OM4515700130DePuy Mitek4515700132026-03-19
B504OM50715940Conmed Linvatec5071-5942026-03-19
B504OMDC119090180Conmed LinvatecDC119-090-182026-03-19
B504OMPDS2NL300NakanishiPDS-2NL-302026-02-09
B504OM13090119XG10Zimmer13090119XG12025-11-25
B504OM19100119XG10Zimmer19100119XG12025-11-25
B504OM20090119XC10Zimmer20090119XC12025-11-25
B504OM20100119XC10Zimmer20100119XC12025-11-25
B504OM20100119XCW0Zimmer20100119XCW2025-11-25
B504OM21090119XGW0Zimmer21090119XGW2025-11-25
B504OM17090127YGS0Zimmer17090127YGS2025-09-03
B504OM0145080Smith and Nephew0145082025-06-19
B504OM254400111D0DePuy Mitek2544-00-111-D2025-06-10
B504OM254400111P0DePuy Mitek2544-00-111-P2025-06-10
B504AS35ULTSTZZ0Conmed Linvatec35ULT-ST-ZZ2017-12-01
B504AS42FRRRAZZ0Conmed Linvatec42FRR-RA-ZZ2017-12-01
B504AS9247A0Conmed Linvatec9247A2017-12-01
B504AS9297A0Conmed Linvatec9297A2017-12-01
B504AS9299A0Conmed Linvatec9299A2017-12-01
B504AS9399A0Conmed Linvatec9399A2017-12-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
M99592200250BFR3PTS BFR Tourniquet Instrument & Throwing Cuff Set Delfi Medical Innovations IncKCY2026-01-14
M99597580018L1BFR Throwing Cuff, Reusable Delfi Medical Innovations IncKCY2026-01-14
M99597580018R1BFR Throwing Cuff, Reusable Delfi Medical Innovations IncKCY2026-01-14
M99597580021R1BFR Throwing Cuff, Reusable Delfi Medical Innovations IncKCY2026-01-14
M995995000181Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995995000241Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995995000301Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995995000341Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995995000421Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995996000181Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995996000241Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995996000301Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995996000341Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
08809802646971DTS-3000DAESUNG MAREF CO.,LTD.KCY2025-12-19
08809802646988DTS-3000DAESUNG MAREF CO.,LTD.KCY2025-12-19
08809802646995DTS-3000DAESUNG MAREF CO.,LTD.KCY2025-12-19
M99592500002BFR1PTS for BFR Generation 3 - Dual Channel SystemDelfi Medical Innovations IncKCY2025-06-17
16976514770009Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770016Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770023Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770030Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770047Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770054Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770061Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770078Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770085Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770092Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770108Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770115Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770122Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23