FDA.report

OmniSafeTM

Primary DI
50810572002198
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LRRFirst Aid Kit with drug

Product Code Classifications

CodeDeviceSpecialtyClass
LRRFirst Aid Kit With DrugUnknownN

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50810572002198PackageGS112In Commercial Distribution
00810572002193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5081057200219850810572002198
00810572002193008105720021938105720021930810572002193

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(603)471-1499Info@Omnigloves.com

Regulatory Flags

DUNS number
079434709
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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 DIBrandModelCatalogPublished
50810572002211OmniTrust315-11315-112025-05-15
10810572002220OmniTrust315-12315-122025-05-15
50810572002235OmniTrust315-13315-132025-05-15
50810572002242OmniTrust315-14315-142025-05-15
50810572000439OmniTrust201-225201-2252025-01-31
50810572003485OmniTrust201-120201-1202025-01-31
50810572003539OmniTrust201-125201-1252025-01-31
50810572003546OmniTrush201-220201-2202025-01-31
50810572004550OmniTrust413-00413-002024-07-23
50810572004567OmniTrust413-01413-012024-07-22
50810572004581OmniTrust413-03413-032024-07-22
50810572004574OmniTrust413-02413-022024-07-22
50810572004598OmniTrust413-04413-042024-07-22
50810572004482OmniTrust2155-402155-402024-02-05
50810572004499OmniTrust2155-412155-412024-02-05
50810572004505OmniTrust2155-422155-422024-02-05
50810572004512OmniTrust2155-432155-432024-02-05
50810572004529OmniTrust2155-442155-442024-02-05
50810572004536OmniTrust2155-452155-452024-02-05
50810572004420OmniTrust217-20217-202024-01-22

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00842209138111NARNORTH AMERICAN RESCUE, LLCLRR2026-03-24
00842209138142NARNORTH AMERICAN RESCUE, LLCLRR2026-03-24
00842209138197NARNORTH AMERICAN RESCUE, LLCLRR2026-03-24
10816058013186DC SafetyDC Safety SalesLRR2026-03-23
06942509220357OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-03-13
06942509220364OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-03-13
06942509220371OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-03-13
00850070635141KIT, FIRST AIDNar Medical Depot, LLCLRR2026-03-12
00842209137893NARNORTH AMERICAN RESCUE, LLCLRR2026-03-10
00842209138043NARNORTH AMERICAN RESCUE, LLCLRR2026-03-10
00842209138074NARNORTH AMERICAN RESCUE, LLCLRR2026-03-10
20017276241338Bluey First Aid KitAso LLCLRR2026-03-03
00766588127675RR - UP Vehicle - 75 RefillCertified Safety Manufacturing, Inc.LRR2026-03-02
00766588249810Class B 21 ANSI Plus - RTB 5186Certified Safety Manufacturing, Inc.LRR2026-03-02
0076658825009050 Person Contractors Kit - 24 Poly WhiteCertified Safety Manufacturing, Inc.LRR2026-03-02
00842209137381NARNORTH AMERICAN RESCUE, LLCLRR2026-02-10
00842209137398NARNORTH AMERICAN RESCUE, LLCLRR2026-02-10
00842209137411NARNORTH AMERICAN RESCUE, LLCLRR2026-02-10
00842209137428NARNORTH AMERICAN RESCUE, LLCLRR2026-02-10
00842209137442NARNORTH AMERICAN RESCUE, LLCLRR2026-02-10
00842209137466NARNORTH AMERICAN RESCUE, LLCLRR2026-02-10
00842209137558NARNORTH AMERICAN RESCUE, LLCLRR2026-02-10
00842209137633NARNORTH AMERICAN RESCUE, LLCLRR2026-02-10
00842209137664NARNORTH AMERICAN RESCUE, LLCLRR2026-02-10
00850070635110First Aid KitNar Medical Depot, LLCLRR2026-02-09
00766588235998QF C-Protector Mouth-to-Mouth BarrierCertified Safety Manufacturing, Inc.LRR2026-02-05
00766588251035PG&E Field Class B 21 Plus - Jump Bag 5210Certified Safety Manufacturing, Inc.LRR2026-02-05
00766588252070Snake Bite EconomyCertified Safety Manufacturing, Inc.LRR2026-02-05
00766588252087PG&E Expirables - ZLBCertified Safety Manufacturing, Inc.LRR2026-02-05
00766588260013Safety General PurposeCertified Safety Manufacturing, Inc.LRR2026-02-05