FDA.reportPublic FDA data

Rescue Breather CPR Protective Barrier

Primary DI
17540195055077
Brand
Rescue Breather CPR Protective Barrier
Company
O-Two Medical Technologies Inc
Model
01RB2020-Royal Blue-U
Catalog number
01RB2020-RB
Device description
The Rescue Breather consists of a one-way valve that has a large block is placed in a patient's mouth, The person providing CPR then blows through the valve to inflate patient's lung. The intended purpose of the valve and the filter is to prevent any cross contamination and potential cross infection by preventing contact with body fluids such as vomit, blood or saliva between patient and first aid provider. Each Rescue Breather is packed with a pair of gloves in a Royal Blue nylon keychain/belt pouch.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYMDevice, Cpr Assist

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYMDevice, Cpr Assist

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K940927000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K940927000RESCUE BREATHERO-Two Systems Intl., Inc.1994-10-14CBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17540195055077PackageGS150In Commercial Distribution
07540195055070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1754019505507717540195055077
07540195055070075401950550707540195055070

GMDN Terms#

Term, Definition table
TermDefinition
Face splash shield, single-useA clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is commonly known as a splash shield. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-387-3405cs@otwo.com

Regulatory Flags#

DUNS number
206449154
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540195015029O-Two 17MP13292023-11-07
07540195015036O-Two 17MP11302023-11-07
07540195020252O Two 01DV2000-FER2024-04-29
07540195020269O Two 01DV2000-FER2024-04-29
17540195040073Pro NoxCMI-0100-PNX 2023-11-13
07540195015012O-Two 08GL1042U2023-11-07
07540195050051O-Two 01FCO115D2023-11-07
07540195050075O-Two 01FCO125D2023-11-07
07540195035157O-Two 01CV02202023-06-22
17540195035154O-Two 01CV02202023-06-22
07540195060111O-TWO 01RO01O10-B2023-06-06
07540195060241O-TWO 01RO01O23-B2023-06-06
07540195086616O-TWO 01RN09N10-B2023-06-06
07540195005174O-Two01CV801501CV8015-CS2019-05-31
07540195005181O-Two01CV801601CV8016-CS2019-05-31
07540195005211O-Two01CV801901CV8019-CS2019-05-31
07540195005334O-Two01CV803001CV8030-CS2019-05-31
07540195005129O-Two01CV801001CV8010-CS2019-05-31
07540195071308O-Two02RT101002RT1010-CS2019-10-31
07540195071322O-Two02RT101202RT1012-CS2019-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00634376095577RONDEX CPR ISO-SHIELD (Made in USA) w Key Ring/Belt Loop Case & GlovesRONDEX PRODUCTS, INCORPORATEDLYM2020-09-03
00634376098073RONDEX CPR REDI-SHIELD (Made in USA) in poly bag and glovesRONDEX PRODUCTS, INCORPORATEDLYM2020-09-03
00634376098509RONDEX CPR REDI-SHIELD (Made in USA) with key ring caseRONDEX PRODUCTS, INCORPORATEDLYM2020-09-03
00634376098578RONDEX CPR REDI-SHIELD (Made in USA) in key ring case with glovesRONDEX PRODUCTS, INCORPORATEDLYM2020-09-03
00634376095003Rondex CPR ISO-SHIELD (Made in USA) w poly bagRONDEX PRODUCTS, INCORPORATEDLYM2020-07-26
00634376098004RONDEX CPR REDI-SHIELD (Made in USA) poly bagRONDEX PRODUCTS, INCORPORATEDLYM2020-07-09
00634376195574CINTAS CPR ISO-SHIELD (Made In USA) w Black Key Ring/Belt Loop Case & Gloves RONDEX PRODUCTS, INCORPORATEDLYM2020-07-07
06343760498576HEALTH & SAFETY INSTITUTE (HSI) CPR REDI-SHIELD (Made in USA)RONDEX PRODUCTS, INCORPORATEDLYM2019-12-10
06343760098073RONDEX CPR REDI-SHIELD (Made in USA) in poly bag and glovesRONDEX PRODUCTS, INCORPORATEDLYM2017-07-20
06343760098516RONDEX CPR REDI-SHIELD (Made in USA) in zipper key ring caseRONDEX PRODUCTS, INCORPORATEDLYM2017-07-14
06343760395509EMS SAFETY CPR ISO-SHIELD (Made in USA) w key ring/belt loop caseRONDEX PRODUCTS, INCORPORATEDLYM2017-07-14
06343760398500EMS SAFETY CPR REDI-SHIELD (Made in USA) with key ring flap closure caseRONDEX PRODUCTS, INCORPORATEDLYM2017-07-14
06343760398517EMS SAFETY CPR REDI-SHIELD (Made in USA) with zipper key ring caseRONDEX PRODUCTS, INCORPORATEDLYM2017-07-14
06343760098004RONDEX CPR REDI-SHIELD (Made in USA) in poly bagRONDEX PRODUCTS, INCORPORATEDLYM2016-11-01
06343760098509RONDEX CPR REDI-SHIELD (Made in USA) in key ring caseRONDEX PRODUCTS, INCORPORATEDLYM2016-11-01
06343760098578RONDEX CPR REDI-SHIELD (Made in USA) w key ring case & gloves RONDEX PRODUCTS, INCORPORATEDLYM2016-11-01
06343760095072Rondex CPR ISO-SHIELD (Made In USA) w poly bag & glovesRONDEX PRODUCTS, INCORPORATEDLYM2016-10-30
06343760095003Rondex CPR ISO-SHIELD (Made In USA) w poly bag RONDEX PRODUCTS, INCORPORATEDLYM2016-10-06
06343760095508Rondex CPR ISO-SHIELD (Made In USA) w Key Ring/Belt Loop CaseRONDEX PRODUCTS, INCORPORATEDLYM2016-10-06
06343760095577Rondex CPR ISO-SHIELD (Made In USA) w Key Ring/Belt Loop Case & GlovesRONDEX PRODUCTS, INCORPORATEDLYM2016-10-06
06343760195574CINTAS CPR ISO-SHIELD (Made In USA) w Black Key Ring/Belt Loop Case & Gloves RONDEX PRODUCTS, INCORPORATEDLYM2016-10-06
06343760295571CINTAS CPR ISO-SHIELD (Made In USA) w Orange Key Ring/Belt Loop Case & GlovesRONDEX PRODUCTS, INCORPORATEDLYM2016-10-06
07540195055049Rescue Breather CPR Protective BarrierO-Two Medical Technologies IncLYM2016-09-23
07540195055063Rescue Breather CPR Protective barrierO-Two Medical Technologies IncLYM2016-09-23
07540195055070Rescue Breather CPR Protective BarrierO-Two Medical Technologies IncLYM2016-09-23
07540195055018Rescue BreatherO-Two Medical Technologies IncLYM2016-09-23
07540195055025Rescue Breather CPR Protective BarrierO-Two Medical Technologies IncLYM2016-09-23
07540195055032Rescue Breather CPR Protective BarrierO-Two Medical Technologies IncLYM2016-09-23
17540195055046Rescue Breather CPR Protective BarrierO-Two Medical Technologies IncLYM2016-09-23
07540195055056Rescue Breather CPR Protective BarrierO-Two Medical Technologies IncLYM2016-09-23