FDA.reportPublic FDA data

36M - Heba Fire & Safety

Primary DI
00766588051369
Brand
36M - Heba Fire & Safety
Company
Certified Safety Manufacturing, Inc.
Model
K605-136
Catalog number
K605-136
Device description
36M - 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
EFQGAUZE/SPONGE, INTERNAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFQGauze/Sponge, InternalUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00766588051369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00766588051369007665880513697665880513690766588051369

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
10192253067880ASOCardinal Health 200, LLCEFQ2026-01-20
00766588235745628 - Non-Stick Pads 2"x 3" - 4/unitCertified Safety Manufacturing, Inc.EFQ2025-12-17
30192253045905CurityCardinal Health 200, LLCEFQ2024-11-12
50192253045916CurityCardinal Health 200, LLCEFQ2024-09-10
10630094194117Bioseal Inc.BIOSEALEFQ2023-10-11
50192253047521CurityCardinal Health 200, LLCEFQ2023-10-09
50192253047569CurityCardinal Health 200, LLCEFQ2023-10-09
50732224004254Preminum All-Gauze SpongesCROSSTEX INTERNATIONAL, INC.EFQ2023-07-17
50732224004261Preminum All-Gauze SpongesCROSSTEX INTERNATIONAL, INC.EFQ2023-07-17
50732224004278Preminum All-Gauze SpongesCROSSTEX INTERNATIONAL, INC.EFQ2023-07-17
50732224004285Preminum All-Gauze SpongesCROSSTEX INTERNATIONAL, INC.EFQ2023-07-17
50732224004292Preminum All-Gauze SpongesCROSSTEX INTERNATIONAL, INC.EFQ2023-07-17
50732224004308Preminum All-Gauze SpongesCROSSTEX INTERNATIONAL, INC.EFQ2023-07-17
50732224004247All-Gauze Sponges PremiumCROSSTEX INTERNATIONAL, INC.EFQ2023-06-22
00766588110110637 - Certi-Gauze Pads - 3"x 3" - 4/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110141638 - Certi-Gauze Compress - 18"x 36" - 2/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110172639 - Certi-Gauze Compress - 36"x 36" - 1/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110219640 - Certi-Gauze Compress - 24"x 72" - 1/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110301628 - Certi-Non-Stick Pads - 2"x 3" - 4/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588310039Certi-Non Stick Pads - 2"x 3" - 25/BoxCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588312057Certi-Gauze Pads - 3"x 3" - 100/BoxCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588312095Certi-Gauze Pads - 2"x 2" - 25/BoxCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588312101Certi-Gauze Pads - 3"x 3" - 10/BoxCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588312118Certi-Gauze Pads - 3"x 3" - 25/BoxCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588312132Certi-Gauze Pads - 4"x 4" - 25/BoxCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110028622 - Certi-Gauze Bandage Compress - 2" - 4/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110059623 - Certi-Gauze Bandage Compress - 3" - 2/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110080624 - Certi-Gauze Bandage Compress - 4" - 1/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110240634 - Certi-Gauze Roll - 2" x 6 yards - 2/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110271635 - Certi-Gauze Roll - 4" x 6 yards - 1/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27