FDA.reportPublic FDA data

DynaSafety CPR Shields In Soft Cases, With One-Way Valve and Barrier Filter

Primary DI
00840117309890
Brand
DynaSafety CPR Shields In Soft Cases, With One-Way Valve and Barrier Filter
Company
Dynarex Corporation
Model
36021
Published
2022-05-14
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

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
00840117309890PrimaryGS10
00810180847353Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117309890008401173098908401173098900840117309890
00810180847353008101808473538101808473530810180847353

GMDN Terms#

Term, Definition table
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.

Regulatory Flags#

DUNS number
008124539
Device count
100
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
true
Expiration date on label
false
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
00840117308855Resp-O2 Dry Bubble Humidifier, 6 PSI (Home Use), 400 mL342212022-05-11
00616784431321Junior Tongue Depressors, 5 1/2" (14.0 cm)43132021-09-01
00616784431420Senior Tongue Depressors, 6" (15.2 cm)43142021-09-01
00616784435213Gait Belt, Natural Colors, Metal Buckle, 60" x 2"43522021-09-01
00616784435312Gait Belt, Multicolor, Metal Buckle, 60" x 2"43532021-09-01
00616784435411Gait Belt, Multicolor, Wipeable Plastic Buckle, 60" x 2"43542021-09-01
00616784351612Heavy Duty Fitted Cot Sheet, White, 30" x 73"35162021-09-01
00616784351711Premium Flat Cot Sheet, Dark Blue, 40" x 85"35172021-09-01
00616784368115Triangular Bandages, Non-Woven, Polybagged, 40" x 40" x 56"36812021-09-01
00616784369228Cotton Stockinette, Soft Stretch Bandage, 2" x 25 yd36922021-09-01
00616784369327Cotton Stockinette, Soft Stretch Bandage, 3" x 25 yd36932021-09-01
00616784369426Cotton Stockinette, Soft Stretch Bandage, 4" x 25 yd36942021-09-01
00616784369624Cotton Stockinette36962021-09-01
00840117349841IV Administration Sets, Non-Toxic, 20 Drops/mL, 84" (213.4 cm)70552026-06-30
00616784201221Lab Jackets Knitted Cuffs & Collar with Pockets, Small, Blue20122021-09-01
00616784201320Lab Jackets Knitted Cuffs & Collar with Pockets, Medium, Blue20132021-09-01
00616784201429Lab Coats Knitted Cuffs & Collar with Pockets, Large, Blue20142021-09-01
00616784201528Lab Jackets Knitted Cuffs & Collar with Pockets, X-Large, Blue20152021-09-01
00616784201627Lab Jackets Knitted Cuffs & Collar with Pockets, 2X-Large, Blue20162021-09-01
00616784206226Lab Coats Knitted Cuffs & Collar with Pockets, Small, White20622021-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946430427199CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCBP2026-08-08
06946430426185GFAXIAMEN COMPOWER MEDICAL TECH. CO., LTDCBP2026-06-01
B448260103XpectFirstar Healthcare Company Limited (Guangzhou)CBP2026-05-13
10889483570562AirLife™AIRLIFECBP2025-03-28
B0023000X0RescuerB.L.S. Systems LimitedCBP2023-12-11
09420012445261Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCBP2023-07-06
00634376498507(HEALTH & SAFETY INSTITUDE) HSI CPR REDI-SHIELD (Made in USA) with key ring caseRONDEX PRODUCTS, INCORPORATEDCBP2023-01-02
00634376498576(HEALTH & SAFETY INSTITUTE) HSI CPR REDI-SHIELD with keyring case & gloves RONDEX PRODUCTS, INCORPORATEDCBP2023-01-02
0076658801349724M - Tampa Electric Co.Certified Safety Manufacturing, Inc.CBP2022-07-15
0076658802201724M - Salt River Project-21 - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588030111XLP - Toyota - Black - XLPouchCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588049045HSB - BBP - Southern Co.Certified Safety Manufacturing, Inc.CBP2022-07-15
0076658806057625M - First Aid Kit - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658806123824PW - Turtle Top Florida DOT - Poly WhiteCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588070650EMT Trauma Care - Red Cordovia BagCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658808074136M - Enbridge - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658809053510PC - Rail America Locomotive - PolyCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588090610Emergency Trauma Care Deluxe - Orange Co-Polymer CaseCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588100029Sports Bag - Fanny PackCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658810093710PW - Head Start - Poly WhiteCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588107042SB-2 - Head Start - Fanny PackCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658810957210M - Sempra - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658811012710PC - UP - 380-54620 - LocamotiveCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812001010M - State of South Dakota DOT BBP - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812068310PW - Hawaiian TelecomCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812072018PR - First Aid Complete Kit - Poly RedCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812082916PW - PCI Construction - Poly WhiteCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588121079FAC-4 - Miller & Long ConcreteCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812966275V - UP Facilities - RefillCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658813049136M - PacifiCorp - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15