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
00822045428805SAM Soft Shell SplintSS544-EN2022-09-01
00822045428812SAM Soft Shell Splint XLSS545-EN2022-09-01
00822045428836SAM Soft Shell SplintSS542-EN2022-09-01
00822045428843SAM Soft Shell Splint XLSS543-EN2022-09-01
00822045428867SAM Soft Shell SplintSS540-EN2022-09-01
00822045428874SAM Soft Shell Splint XLSS541-EN2022-09-01
00822045428881SAM Sugar Tong SplintST560-EN2022-09-01
00822045428898SAM Sugar Tong SplintST561-EN2022-09-01
00822045428935SAM Sugar Tong SplintST562-EN2022-09-01
00822045001503SAM ThoraSite®TS200-1P2025-12-12
10822045000305SAM IO Intraosseous Access SystemIO740-5P-EN2020-05-28
00822045000308SAM IO Intraosseous Access SystemIO740-1P-EN2020-05-28
00822045000001Chito-SAM™ 100CT100-C-EN2022-09-01
00822045000025Chito-SAM™ 100CT100-A-EN2022-09-01
00822045000339Chito-SAM™ 100CT100-B-EN2022-09-01
00822045000926SAM XT Extremity TourniquetXT700-BL-EN2024-11-14
00822045001039SAM XT Extremity TourniquetXT700-OR-EN2024-11-14
00822045000889SAM XT Extremity TourniquetXT700-BK-EN2024-11-14
10822045000923SAM XT Extremity TourniquetXT700-BL-EN2024-11-14
10822045001036SAM XT Extremity TourniquetXT700-OR-EN2024-11-14

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Primary DI, Brand, Company table
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10197344138890NAMICMEDLINE INDUSTRIES, INC.DXC2026-03-16
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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
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