FDA.reportPublic FDA data

Hygenic

Primary DI
00087453073461
Brand
Hygenic
Company
HYGENIC CORPORATION, THE
Model
07346
Device description
"1""x18""x.025 T-STRAP 10/100 PKG, Latex Tourniquet Strap"
Published
2019-04-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
20087453073465PackageGS110In Commercial Distribution
00087453073461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2008745307346520087453073465
00087453073461000874530734610874530734610087453073461

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18Inch
Width0.75Inch

Regulatory Flags#

DUNS number
004163390
Device count
1
Premarket exempt
true
Lot or batch
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00087453001662Hygenic155832026-01-13
00087453001679Hygenic155842026-01-13
00087453127560TheraBand Kinesiology Tape127562025-03-11
00087453127577TheraBand Kinesiology Tape127572025-03-11
00087453127584TheraBand Kinesiology Tape127582025-03-11
00087453143478Hysynal143472025-03-10
00087453127409TheraBand Kinesiology Tape127402025-03-10
00087453127447TheraBand Kinesiology Tape127442025-03-10
00087453127454TheraBand Kinesiology Tape127452025-03-10
00087453127461TheraBand Kinesiology Tape127462025-03-10
00087453127478TheraBand Kinesiology Tape127472025-03-10
00087453127492TheraBand Kinesiology Tape127492025-03-10
20087453143472Hysynal143472025-03-10
00087453127393TheraBand Kinesiology Tape127392025-03-10
00087453127416TheraBand Kinesiology Tape127412025-03-10
00087453102048Hysynal102042019-04-08
00087453127515TheraBand Kinesiology Tape 127512019-02-08
00087453127522TheraBand Kinesiology Tape 127522019-02-08
00087453127539TheraBand Kinesiology Tape 127532019-02-08
00087453127546TheraBand Kinesiology Tape 127542019-02-08

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
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
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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