FDA.reportPublic FDA data

SAM(R) Junctional Tourniquet

Primary DI
00822045000124
Brand
SAM(R) Junctional Tourniquet
Company
SAM Medical Products
Model
SJT115
Device description
SAM Junctional Tourniquet - Auxiliary Strap
Published
2016-10-01
Public version status
Update
Distribution status
Not 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
00822045000124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822045000124008220450001248220450001240822045000124

GMDN Terms#

Term, Definition table
TermDefinition
Arm/leg tourniquet, single-useA non-sterile strap or tubing intended to be wrapped around a patient's limb (arm or leg) and manually tightened to reduce blood circulation to or from the portion of the limb distal to where the device is applied. It is typically used by emergency medical services (EMS) for emergency blood loss prevention or for routine blood sampling. It typically does not include latex and may be available in a variety of designs (e.g., Velcro or a self-locking buckle, synthetic rubber band). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
503-639-5474customerservice@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
00822045000001Chito-SAM™ 100CT100-C-EN2022-09-01
00822045000025Chito-SAM™ 100CT100-A-EN2022-09-01
00822045000254SAM Bleeding Control KitKT901-V-EN2022-09-01
00822045000261SAM Bleeding Control KitKT901-NV-EN2022-09-01
00822045000339Chito-SAM™ 100CT100-B-EN2022-09-01
00822045000391SAM® Junctional TourniquetJT403-EN2020-04-01
00822045428744SAM SplintSP510-OB-EN2022-09-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776411527MillenniumAvalign Technologies, Inc.DXC2026-08-07
00190776408633MillenniumAvalign Technologies, Inc.DXC2026-08-03
00190776422318MillenniumAvalign Technologies, Inc.DXC2026-07-31
00885403523000FOGARTY SOFTJAWBecton, Dickinson And CompanyDXC2026-07-30
00885403523161FOGARTY HYDRAJAWBecton, Dickinson And CompanyDXC2026-07-30
00885403523253FOGARTY SOFTJAWBecton, Dickinson And CompanyDXC2026-07-30
00885403523277FOGARTY SOFTJAWBecton, Dickinson And CompanyDXC2026-07-30
10841156102012D-STATTELEFLEX INCORPORATEDDXC2026-07-30
00190776404178MillenniumAvalign Technologies, Inc.DXC2026-07-24
00190776404185MillenniumAvalign Technologies, Inc.DXC2026-07-24
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
00822045000391SAM® Junctional TourniquetSAM Medical ProductsDXC2020-04-01
20884521152134CovidienCardinal Health, Inc.DXC2016-09-24
M20630300D-Stat® Clamp topical hemostat accessoryVascular Solutions, Inc.DXC2016-09-15