FDA.reportPublic FDA data

FAC-4 - Class B + Meds - 4 Shelf Cabinet

Primary DI
00766588160665
Brand
FAC-4 - Class B + Meds - 4 Shelf Cabinet
Company
Certified Safety Manufacturing, Inc.
Model
K616-066
Catalog number
K616-066
Device description
FAC-4 - Class B + Meds - 4 Shelf Cabinet
Published
2018-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBPValve, non-rebreathing
EFQGAUZE/SPONGE, INTERNAL
HMPPAD, EYE
IMDPACK, HOT OR COLD, DISPOSABLE
KGXTape and bandage, adhesive
LRRFirst Aid Kit with drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBPValve, Non-RebreathingAnesthesiology2
EFQGauze/Sponge, InternalUnknownU
HMPPad, EyeGeneral, Plastic Surgery1
IMDPack, Hot Or Cold, DisposablePhysical Medicine1
KGXTape And Bandage, AdhesiveGeneral Hospital1
LRRFirst Aid Kit With DrugUnknownN

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K940249000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K940249000CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSINGCertified Safety Mfg., Inc.1994-10-03LRR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00766588160665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00766588160665007665881606657665881606650766588160665

GMDN Terms#

Term, Definition table
TermDefinition
Adhesive bandageA sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). 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
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00766588260112Class A 21 - Grab-N-Go Large - Red Velcro BagK626-011K626-0112026-06-04
00766588283463Cohesive Wrap - 2"x 5 ydsR228-346R228-3462026-06-04
10766588283460Cohesive Wrap - 2"x 5 yds - UDI/10R228-346R228-3462026-06-04
00766588260037Naloxone - 16 Poly ClearK626-003K626-0032026-05-26
00766588420103Forceps - MagnifierR242-010R242-0102026-05-26
10766588420100Forceps - Magnifier UDI/10R242-010R242-0102026-05-26
00766588260099Cement Burn Cabinet - 75H 2 Shelf CabinetK626-009K626-0092026-05-04
00766588090177FAA SWA on Board PPE Bag - ZLBFK209-017FK209-0172026-04-29
00766588090160FAA SWA BioHazard Clean Up Bag - ZLBFK209-016FK209-0162026-04-16
00766588260044Class B 21 BloodBorne Pathogen - 75H CabinetK626-004K626-0042026-04-16
00766588260075So Cal Gas Wilderness Tactical Class B 21 - Jump Bag 5210K626-007K626-0072026-04-16
00766588260020Naloxone - 10 Poly WhiteK626-002K626-0022026-04-06
00766588260068Burn Dressing Large - Red Velcro BagK626-006K626-0062026-04-06
00766588247045Heat Stress - 16 Poly WhiteK624-904K624-9042025-03-24
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
00766588235714"607 QF Strips Plastic 1""x 3"" 16/Box"R523-571R523-5712026-02-05
00766588235998QF C-Protector Mouth-to-Mouth BarrierR523-599R523-5992026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00049696189583THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696561228THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696561518B.PUREFOURSTAR GROUP INC.IMD2026-06-09
00049696562102B.PUREFOURSTAR GROUP INC.IMD2026-06-09
00049696677547THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00197344129099CURADMEDLINE INDUSTRIES, INC.KGX2026-06-09
08809302586364Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586395Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586425Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586487Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
00766588260112Class A 21 - Grab-N-Go Large - Red Velcro BagCertified Safety Manufacturing, Inc.LRR2026-06-04
00888277719081RexallMEDLINE INDUSTRIES, INC.LRR2026-06-03
06946430426185GFAXIAMEN COMPOWER MEDICAL TECH. CO., LTDCBP2026-06-01
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00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCKGX2026-05-31
00850087488389CeeportCEEPORT INC.KGX2026-05-29
00850087488426CeeportCEEPORT INC.KGX2026-05-29
00050428142516CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-05-28
00842209138890NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138906NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138913NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138920NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138944NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
00842209138951NARNORTH AMERICAN RESCUE, LLCLRR2026-05-27
08436587170522ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-18
08436587170010ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170027ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170065ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170102ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15