FDA.reportPublic FDA data

36M - Salt River Project-31 - Metal

Primary DI
00766588022024
Brand
36M - Salt River Project-31 - Metal
Company
Certified Safety Manufacturing, Inc.
Model
K202-202
Catalog number
K202-202
Device description
36M - Salt River Project-31 - Metal
Published
2022-07-15
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBPValve, non-rebreathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBPValve, Non-RebreathingAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00766588022024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00766588022024007665880220247665880220240766588022024

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, non-antimicrobialA wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. 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
B448FS1040Seal QuikFirstar Healthcare Company Limited (Guangzhou)CBP2025-12-10
16946430423013Lightning X Products, IncXIAMEN COMPOWER MEDICAL TECH. CO., LTDCBP2025-06-14
0503026716528522MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVEIntersurgical IncorporatedCBP2025-04-15
30889483570566AirLife™Sunmed Group Holdings, LLCCBP2025-03-28
16946430421941MENDYOUMEDICALXIAMEN COMPOWER MEDICAL TECH. CO., LTDCBP2024-11-26
00850055775022BIG EASY, NON-REBREATHING VALVEINNOVATION INSTITUTE, LLCCBP2024-10-30
0503026704086522MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM. 1.6MIntersurgical IncorporatedCBP2024-09-16
09420012480149Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCBP2024-09-11
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04719871890110LIFEGUARDFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
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04719871890615MEDSTORMFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890622LIFEGUARDFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
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04719871890691FOREMOUNTFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890707WorldPointFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890714Top SafetyFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890721Top SafetyFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890738WorldPointFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28