FDA.reportPublic FDA data

INNOVATE MEDICAL

Primary DI
00852937003285
Brand
INNOVATE MEDICAL
Company
INNOVATE MEDICAL, LLC
Model
820-5412
Catalog number
820-5412
Device description
Innovate Medical Esmark Bandage Blue 4x12
Published
2022-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
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
10852937003282PackageGS11In Commercial Distribution
40852937003283PackageGS120In Commercial Distribution
00852937003285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085293700328210852937003282
4085293700328340852937003283
00852937003285008529370032858529370032850852937003285

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.

Contacts#

Phone, Email table
PhoneEmail
423-461-3558QA@innovatemed.com

Regulatory Flags#

DUNS number
050339980
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852937003087HCTHCT9849-12023-03-17
00852937003070HCTHCTBBD-1002023-08-08
00852937003025INNOVATE MEDICAL10-2000-0110-2000-012022-11-14
00852937003032INNOVATE MEDICAL9-204099-204092022-11-14
00852937003049INNOVATE MEDICAL9-204129-204122022-11-14
00852937003056INNOVATE MEDICAL9-206099-206092022-11-14
00852937003063INNOVATE MEDICAL9-206129-206122022-11-14
00852937003278INNOVATE MEDICAL820-5409820-54092022-11-14
00852937003292INNOVATE MEDICAL820-5609820-56092022-11-14
00852937003308INNOVATE MEDICAL820-5612820-56122022-11-14
00852937003018INNOVATE MEDICAL10-1001-0410-1001-042022-11-14
10852937003022INNOVATE MEDICAL10-2000-0110-2000-012022-11-14
10852937003039INNOVATE MEDICAL9-204099-204092022-11-14
10852937003046INNOVATE MEDICAL9-204129-204122022-11-14
10852937003053INNOVATE MEDICAL9-206099-206092022-11-14
10852937003060INNOVATE MEDICAL9-206129-206122022-11-14
10852937003275INNOVATE MEDICAL820-5409820-54092022-11-14
10852937003282INNOVATE MEDICAL820-5412820-54122022-11-14
10852937003299INNOVATE MEDICAL820-5609820-56092022-11-14
10852937003305INNOVATE MEDICAL820-5612820-56122022-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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