FDA.reportPublic FDA data

JMU

Primary DI
00840456222164
Brand
JMU
Company
JMU DENTAL, INC
Model
46336002
Device description
"JMU Elastic Rolled Tourniquet, Non-Latex, Blue TPE, 1"" x 18"", Single-Use, Box of 100 Rolls (Sold by Box)"
Published
2026-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00840456222164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840456222164008404562221648404562221640840456222164

GMDN Terms#

Term, Definition table
TermDefinition
Tourniquet cuff bandage, non-latexA sterile strip or roll of non-latex containing material that is applied around an extremity (arm or leg) before the fitting of a tourniquet cuff on top of it. This device is used to protect the patient's skin from wrinkling, pinching or shearing and to protect the tourniquet cuff from becoming soiled with blood and other fluids from the operative site. It would typically be folded back over the exposed edges of the cuff to provide maximum protection. This is a single-use device.

Regulatory Flags#

DUNS number
081258380
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840456201053JMU321130012026-06-05
00840456201060JMU321130022026-06-05
00840456201077JMU321130032026-06-05
00840456201275JMU321010102026-06-05
00840456201282JMU321010112026-06-05
00840456201299JMU321010122026-06-05
00840456201305JMU321010152026-06-05
00840456201312JMU321010142026-06-05
00840456201831JMU321160012026-06-05
00840456201848JMU321160022026-06-05
00840456201855JMU321160032026-06-05
00840456201862JMU321160042026-06-05
00840456201879JMU321160052026-06-05
00840456201886JMU321160062026-06-05
00840456201893JMU321160072026-06-05
00840456201909JMU321160082026-06-05
00840456201916JMU321160092026-06-05
00840456201923JMU321160102026-06-05
00840456201930JMU321160112026-06-05
00840456201947JMU321160122026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00630094049151Bioseal Inc.BIOSEALGAX2024-01-24