FDA.reportPublic FDA data

FAC-3 - Heba Fire & Safety

Primary DI
00766588130026
Brand
FAC-3 - Heba Fire & Safety
Company
Certified Safety Manufacturing, Inc.
Model
K613-002
Catalog number
K613-002
Device description
FAC-3 - Heba Fire & Safety
Published
2019-05-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
00766588130026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00766588130026007665881300267665881300260766588130026

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze rollA sterile device in the form of a long strip of stretchable, non-woven material (e.g., rayon/polyester), wound into a roll, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(816)483-9090Info@certifiedsafety.com

Regulatory Flags#

DUNS number
788460483
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00766588260037Naloxone - 16 Poly ClearK626-003K626-0032026-05-26
00766588420103Forceps - MagnifierR242-010R242-0102026-05-26
10766588420100Forceps - Magnifier UDI/10R242-010R242-0102026-05-26
00766588260051Burn Dressing Small - Red Velcro BagK626-005K626-0052026-03-23
00766588127675RR - UP Vehicle - 75 RefillKR612-067KR612-0672026-03-02
00766588249810Class B 21 ANSI Plus - RTB 5186K624-981K624-9812026-03-02
0076658825009050 Person Contractors Kit - 24 Poly WhiteK625-009K625-0092026-03-02
00766588235714607 QF Strips Plastic 1"x 3" 16/BoxR523-571R523-5712026-02-05
00766588235998QF C-Protector Mouth-to-Mouth BarrierR523-599R523-5992026-02-05
00766588251035PG&E Field Class B 21 Plus - Jump Bag 5210K625-103K625-1032026-02-05
00766588252070Snake Bite EconomyR525-207R525-2072026-02-05
00766588252087PG&E Expirables - ZLBR525-208R525-2082026-02-05
00766588260013Safety General PurposeK626-001K626-0012026-02-05
00766588250076Safety General Purpose - 10 Poly WhiteK625-007K625-0072025-12-18
00766588235745628 - Non-Stick Pads 2"x 3" - 4/unitR523-574R523-5742025-12-17
00766588120676RR - UP Facilities - 75VK612-067K612-0672025-12-15
00766588235721608 - Adhesive Bandages Plastic 2"x 3" - 6/unitR523-572R523-5722025-12-15
00766588160825816 - Nitrile Gloves - 2 pr/unitR216-082R216-0822025-12-08
00766588190051QF Tape 1/2" x 2.5 yds. - RollR519-005R519-0052025-12-08
00766588250083Safety General Purpose - 16 Poly WhiteK625-008K625-0082025-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00766588260037Naloxone - 16 Poly ClearCertified Safety Manufacturing, Inc.LRR2026-05-26
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