FDA.reportPublic FDA data

10M - Sempra - Metal

Primary DI
00766588109572
Brand
10M - Sempra - Metal
Company
Certified Safety Manufacturing, Inc.
Model
KR610-057
Catalog number
KR610-057
Device description
10M - Sempra - Metal
Published
2022-07-15
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
KGXTape and bandage, adhesive
LRRFirst Aid Kit with drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBPValve, Non-RebreathingAnesthesiology2
EFQGauze/Sponge, InternalUnknownU
KGXTape And Bandage, AdhesiveGeneral Hospital1
LRRFirst Aid Kit With DrugUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00766588109572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00766588109572007665881095727665881095720766588109572

GMDN Terms#

Term, Definition table
TermDefinition
Non-rebreathing valve, single-useA non-sterile device containing a one-way valve intended to be used to direct the flow of breathing gases, typically in a breathing circuit or between an oxygen mask and its reservoir bag, to prevent patient rebreathing of exhaled gases. The device is available in various designs and includes unidirectional valves made of various materials (e.g., silicone, rubber, metal, or mica sheets/discs) that typically open and close with each inspiration/expiration. 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
00766588260143Watercraft First Aid Kit - 16 Poly WhiteK626-014K626-0142026-08-19
00766588260181Teichert Clas A 21 - 18 MetalK626-018K626-0182026-08-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00842209139736NARNORTH AMERICAN RESCUE, LLCLRR2026-08-19
00842209139743NARNORTH AMERICAN RESCUE, LLCLRR2026-08-19
00842209139767NARNORTH AMERICAN RESCUE, LLCLRR2026-08-19
00842209139774NARNORTH AMERICAN RESCUE, LLCLRR2026-08-19
00842209139781NARNORTH AMERICAN RESCUE, LLCLRR2026-08-19
00842209139804NARNORTH AMERICAN RESCUE, LLCLRR2026-08-19
00029369133334McDavidShock Doctor, Inc.KGX2026-08-18
00050428143216CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-08-18
00199972000467CuraplexBOUND TREE MEDICAL, LLCLRR2026-08-15
06946430427199CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCBP2026-08-08
069740214114323H MedicalWAL-MART STORES, INC.KGX2026-07-31
069740214114943H MedicalWAL-MART STORES, INC.KGX2026-07-31
06979191882112NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882228NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882242NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882273BadBuddyWAL-MART STORES, INC.KGX2026-07-31
06979191883591OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883607OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883690EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883706EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883713EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883720EquateWAL-MART STORES, INC.KGX2026-07-31
06980297490019HuixiangJiangsu Huixiang Intelligent Technology Co., LtdKGX2026-07-31
20618125192339AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28