FDA.reportPublic FDA data

CPR Shield

Primary DI
00616784492322
Brand
CPR Shield
Company
DYNAREX CORPORATION
Model
4923
Device description
CPR Shield in Soft Case with one-way valve and barrier filter
Published
2021-09-01
Public version status
New
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052743000DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921Dynarex Corp.2005-12-22CBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784492339PrimaryGS10
00616784492322Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784492339006167844923396167844923390616784492339
00616784492322006167844923226167844923220616784492322

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.

Sterilization Methods#

Method table
Method

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
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117307605Ever-Soft Pommel Gel Foam Cushion 18" x 16" x 3"106852021-04-22
00840117307629Ever-Soft Pommel Gel Foam Cushion 20" x 16" x 3"106862021-04-22
00840117307643Ever-Soft Anti-Thrust Wedge Gel Foam Cushion 18" x 16" x 4" x 2"106902021-04-22
00840117307667Ever-Soft Anti-Thrust Wedge Gel Foam Cushion 20" x 16" x 4" x 2"106912021-04-22
00840117307681Ever-Soft Pommel Wedge Gel Foam Cushion 18" x 16" x 4" x 2"106802021-04-22
00840117307704Ever-Soft Pommel Wedge Gel Foam Cushion 20" x 16" x 4" x 2"106812021-04-22
00840117352476Urinary Drainage Bag Holder 11" x 11" (27.9 cm x 27.9 cm)102612019-10-09
00616784065014Ever-Soft Foam Cushion 16" x 16" x 3"106502021-04-22
00616784065113Ever-Soft Foam Cushion 18" x 16" x 3"106512021-04-22
00616784065212Ever-Soft Foam Cushion 18" x 18" x 3"106522021-04-22
00616784065311Ever-Soft Foam Cushion 20" x 16" x 3"106532021-04-22
00616784065410Ever-Soft Foam Cushion 20" x 18" x 3"106542021-04-22
00840117307568Ever-Soft Coccyx Foam Cushion 18" x 16" x 3"106552021-04-22
00840117307582Ever-Soft Coccyx Foam Cushion 20" x 16" x 3"106562021-04-22
00840117326132Bariatric HD Patient Lift107072023-03-24
00616784067513Ever-Soft Alternating Pressure Air Cushion106752022-05-09
00616784042022DynaRest Multi-Zone Foam Mattress with Perimeter With Perimeter, 36" x 80" x 6"10420P2020-01-15
00616784070414Hydraulic Patient Lift107042019-09-30
00616784070018Electric Patient Lift107002019-09-25
00616784070117Bariatric Electric Patient Lift107012019-09-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946430426185GFAXIAMEN COMPOWER MEDICAL TECH. CO., LTDCBP2026-06-01
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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
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