FDA.reportPublic FDA data

OmniSafeTM

Primary DI
00810572002193
Brand
OmniSafeTM
Company
Omni International Corp.
Model
FAK-0025
Catalog number
FAK-0025
Device description
First Aid Kit
Published
2019-07-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRRFirst Aid Kit with drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRRFirst Aid Kit With DrugUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50810572002198PackageGS112In Commercial Distribution
00810572002193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5081057200219850810572002198
00810572002193008105720021938105720021930810572002193

GMDN Terms#

Term, Definition table
TermDefinition
First aid kit, medicatedA convenient collection of equipment, materials and pharmaceuticals intended to be used in an emergency for the rapid, initial treatment of an injury. It is typically used by emergency medical services (EMS), hospitals, institutions, schools, and other public settings. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(603)471-1499Info@Omnigloves.com

Regulatory Flags#

DUNS number
079434709
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50810572000095OmniTrustTM50325-1950325-192020-12-11
00810572000045OmniTrustTM80250-2980250-292020-12-16
00810572000397OmniTrustTM9112-319112-312020-12-10
00810572000434OmniTrust201-225201-2252025-01-31
00810572000861OmniTrustTM313-11313-112019-09-06
00810572000878OmniTrustTM313-12313-122019-08-27
00810572000885OmniTrustTM313-13313-132019-08-27
00810572000892OmniTrustTM313-14313-142019-08-27
00810572001127OmniTrustTM113-01113-012019-08-27
00810572001134OmniTrustTM113-02113-022019-08-27
00810572001141OmniTrustTM113-03113-032019-08-27
00810572001158OmniTrustTM113-04113-042019-08-27
00810572001165OmniTrustTM212-20212-202019-08-27
00810572001172OmniTrustTM212-21212-212019-08-27
00810572001189OmniTrustTM212-22212-222019-08-27
00810572001196OmniTrustTM212-23212-232019-08-27
00810572001202OmniTrustTM212-24212-242019-08-27
00810572001271OmniTrustTM312-11312-112019-08-27
00810572001288OmniTrustTM312-12312-122019-08-27
00810572001295OmniTrustTM312-13312-132019-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942509220548OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220555OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220562OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220579OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220630OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220654OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220661OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220678OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220739OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220753OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220760OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220777OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220784OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220807OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220814OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220821OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220838OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220845OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220852OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220869OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220876OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220883OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220920OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220937OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
00766588260143Watercraft First Aid Kit - 16 Poly WhiteCertified Safety Manufacturing, Inc.LRR2026-08-19
00766588260181Teichert Clas A 21 - 18 MetalCertified Safety Manufacturing, Inc.LRR2026-08-19
00842209139682NARNORTH AMERICAN RESCUE, LLCLRR2026-08-19
00842209139699NARNORTH AMERICAN RESCUE, LLCLRR2026-08-19
00842209139712NARNORTH AMERICAN RESCUE, LLCLRR2026-08-19
00842209139729NARNORTH AMERICAN RESCUE, LLCLRR2026-08-19