FDA.report

36PW Genesee & Wyoming Fleet - Poly White

Primary DI
00766588149226
Brand
36PW Genesee & Wyoming Fleet - Poly White
Company
Certified Safety Manufacturing, Inc.
Model
K614-022
Catalog number
K614-022
Device description
36PW Genesee & Wyoming Fleet - Poly White
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

Related Records

Contact Domains

Product Codes

CodeName
CBPValve, non-rebreathing

Product Code Classifications

CodeDeviceSpecialtyClass
CBPValve, Non-RebreathingAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00766588149226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00766588149226007665881492267665881492260766588149226

GMDN Terms

TermDefinition
Cardiopulmonary resuscitation mask, single-useA flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS) or as part of first aid kits. This is a single-use device.

Sterilization Methods

Method

Contacts

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 DIBrandModelCatalogPublished
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
00766588069012Gillig Bus 24 - RefillKR606-301KR606-3012025-12-02
00766588042053New Mexico SBK - 24 Poly WhiteS204-205S204-2052025-08-21
00766588089560Mississippi BFK - RefillFKR208-056FKR208-0562025-08-21

Other Devices Sharing Product Codes

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
04719871890011WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890028WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890042WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890059WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890066ARCFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890073WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890080FukuokaFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890097WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890103WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890110LIFEGUARDFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890608WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890615MEDSTORMFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890622LIFEGUARDFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890639WNLFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890646WorldPointFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890653SoutheasternFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
04719871890677FirehouseFOREMOUNT ENTERPRISE CO., LTD.CBP2024-06-28
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