FDA.reportPublic FDA data

SAM XT Extremity Tourniquet

Primary DI
10822045000923
Brand
SAM XT Extremity Tourniquet
Company
SAM Medical Products
Model
XT700-BL-EN
Device description
SAM XT EXTREMITY TOURNIQUET - HI-VIZ BLUE PW
Published
2024-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
10822045000923PackageGS125In Commercial Distribution
00822045000926PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082204500092310822045000923
00822045000926008220450009268220450009260822045000926

GMDN Terms#

Term, Definition table
TermDefinition
Arterial tourniquet, manual, single-useA device in the form of a band or strap intended to be wrapped and manually tightened around a patient's limb (arm or leg) to control/stop life-threatening (emergency) bleeding from an artery (e.g., in a military setting and/or high-risk work environment). It typically includes an adherent layer (e.g., Velcro) and/or a buckle mechanism for fastening/locking that allows adjustments to the degree of tightness. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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 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
40884389110493MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-07-03
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
00842942010897PRIMEDpriMED Medical Products IncGAX2026-03-03
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
05060483571867TMT (Tactical Mechanical Tourniquet)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDGAX2024-10-02
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
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00630094049199Bioseal Inc.BIOSEALGAX2024-01-25
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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