FDA.reportPublic FDA data

SAM® Junctional Tourniquet

Primary DI
00822045000353
Brand
SAM® Junctional Tourniquet
Company
SAM Medical Products
Model
JT400-EN
Device description
SAM Junctional Tourniquet - SJT Belt with 2 TCDs, Auxiliary Strap, Extender, Hand Pump & Bag
Published
2019-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXCClamp, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131561000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131561000SAM JUNCTIONAL TOURNIQUETSam Medical Products2013-07-24DXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10822045000350PackageGS16In Commercial Distribution
00822045000056PreviousGS10
00822045000353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082204500035010822045000350
00822045000056008220450000568220450000560822045000056
00822045000353008220450003538220450003530822045000353

GMDN Terms#

Term, Definition table
TermDefinition
Emergency junctional haemorrhage compression setA collection of non-sterile, noninvasive devices intended to be used in an emergency situation (e.g., battlefield) to provide compression for haemostasis to a traumatic wound occurring proximal to where a limb meets the torso/pelvis. Often referred to as a junctional tourniquet, it consists of a belt(s)/binder(s), an inflatable bulb(s), and a hand pump. The inflatable bulb is intended to be secured at the point of the wound with the belt, then inflated to provide compression and prevent bleeding. The belt component may be additionally intended to be used as a binder. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
5036395474quality@sammedical.com

Regulatory Flags#

DUNS number
131084188
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00822045000179SAM Chest SealCS201-EN2022-09-01
00822045000407SAM SplintSP527-CH-EN-7572022-09-01
00822045000414SAM SplintSP527-OB-EN-5622022-09-01
00822045000438SAM SplintSP527-CH-EN-7732022-09-01
00822045000476SAM SplintSP527-OB-EN-7482022-09-01
00822045000537SAM SplintSP527-OB-EN-8032022-09-01
00822045000544SAM SplintSP527-OB-EN-8042022-09-01
00822045000551SAM Splint XLSP528-CH-EN-7862022-09-01
00822045000575SAM Splint XLSP528-OB-EN-7492022-09-01
00822045000599SAM Splint XLSP528-OB-EN-7742022-09-01
00822045000612SAM SplintSP526-CH-EN-7452022-09-01
00822045000643SAM SplintSP526-BC-EN-7052022-09-01
00822045000667SAM SplintSP526-OB-EN-5052022-09-01
00822045000698SAM SplintSP526-OB-EN-5682022-09-01
00822045000728SAM SplintSP526-OB-EN-7152022-09-01
00822045000742SAM SplintSP526-OB-EN-7722022-09-01
00822045000865SAM SplintSP522-OB-EN-7692022-09-01
00822045000872SAM SplintSP522-CH-EN-7702022-09-01
00822045000896SAM SplintSP524-OB-EN-7712022-09-01
00822045000902SAM SplintSP520-OB-EN-7672022-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776400248MillenniumAvalign Technologies, Inc.DXC2026-07-21
00190776403287MillenniumAvalign Technologies, Inc.DXC2026-07-21
00190776403294MillenniumAvalign Technologies, Inc.DXC2026-07-21
00810220800461Adler Instrument CompanyAdler, Inc.DXC2026-07-17
00190776397180MillenniumAvalign Technologies, Inc.DXC2026-07-16
00190776395605MillenniumAvalign Technologies, Inc.DXC2026-07-14
00190776395698MillenniumAvalign Technologies, Inc.DXC2026-07-14
00190776395711MillenniumAvalign Technologies, Inc.DXC2026-07-14
00192896123557Debakey Neonatal ClampSONTEC INSTRUMENTS, INC.DXC2026-07-10
00846159036152SCANLAN® Bulldog ClampSCANLAN INTERNATIONAL INCDXC2026-06-23
00846159036404SCANLAN® Bulldog ClampSCANLAN INTERNATIONAL INCDXC2026-06-09
00810220800348Adler Instrument CompanyAdler, Inc.DXC2026-06-02
10197344138890NAMICMEDLINE INDUSTRIES, INC.DXC2026-03-16
08022057015884DeTACH Aortic Cross Clamp Head-LargeCORCYM SRLDXC2026-02-03
08022057015907DeTACH Aortic Cross Clamp Head-SmallCORCYM SRLDXC2026-02-03
10193489727173Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DXC2022-08-04
10195594150808CARDINAL HEALTHCardinal Health 200, LLCDXC2021-07-09
20884521152134CovidienCardinal Health, Inc.DXC2016-09-24
M20630300D-Stat® Clamp topical hemostat accessoryVascular Solutions, Inc.DXC2016-09-15
M20635240Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635270Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635290Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635370Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
10381780142935Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14
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10381780142959Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14
10381780142966Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14
10381780142973Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14
10381780142980Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14
10381780142997Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14