FDA.reportPublic FDA data

SAM XT Extremity Tourniquet

Primary DI
00822045000223
Brand
SAM XT Extremity Tourniquet
Company
SAM Medical Products
Model
XT600-BL-EN
Device description
SAM EXTREMITY TOURNIQUET-HI-VIS BLUE
Published
2022-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAXTourniquet, Nonpneumatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10822045000220PackageGS125In Commercial Distribution
00822045000223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082204500022010822045000220
00822045000223008220450002238220450002230822045000223

GMDN Terms#

Term, Definition table
TermDefinition
Limb tourniquet, manual, single-useA 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
5036395474raqa@sammedical.com

Regulatory Flags#

DUNS number
131084188
Device count
1
Premarket exempt
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
40888277362261MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-06-09
20888277414249MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-20
20888277717388MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
40080196774662MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
40080196781462MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
20665973032393DukalDukal LLCGAX2025-04-08
20665973032409DukalDukal LLCGAX2025-04-08
20197344105363MEDLINEMEDLINE INDUSTRIES, INC.GAX2025-03-24
30197344006230MEDLINEMEDLINE INDUSTRIES, INC.GAX2025-03-24
00087453143478HysynalHYGENIC CORPORATION, THEGAX2025-03-10
30382903671992BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-20
30382903672050BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-20
30382903671985BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-13
30382903672098BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-13
00630094049182Bioseal Inc.BIOSEALGAX2024-01-25
00630094049199Bioseal Inc.BIOSEALGAX2024-01-25
00630094049205Bioseal Inc.BIOSEALGAX2024-01-25
00630094049212Bioseal Inc.BIOSEALGAX2024-01-25
00630094049229Bioseal Inc.BIOSEALGAX2024-01-25
00630094049236Bioseal Inc.BIOSEALGAX2024-01-25
00630094049243Bioseal Inc.BIOSEALGAX2024-01-25
00630094049045Bioseal Inc.BIOSEALGAX2024-01-24
00630094049069Bioseal Inc.BIOSEALGAX2024-01-24
00630094049076Bioseal Inc.BIOSEALGAX2024-01-24
00630094049083Bioseal Inc.BIOSEALGAX2024-01-24
00630094049090Bioseal Inc.BIOSEALGAX2024-01-24
00630094049106Bioseal Inc.BIOSEALGAX2024-01-24
00630094049120Bioseal Inc.BIOSEALGAX2024-01-24
00630094049137Bioseal Inc.BIOSEALGAX2024-01-24
00630094049144Bioseal Inc.BIOSEALGAX2024-01-24