FDA.reportPublic FDA data

First Aid Only

Primary DI
00738743000994
Brand
First Aid Only
Company
Acme United Corporation
Model
21-700B
Catalog number
21-700B
Device description
EMT Grade CPR mask
Published
2022-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYPMouthpiece, Breathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYPMouthpiece, BreathingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00738743000994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00738743000994007387430009947387430009940738743000994

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

Contacts#

Phone, Email table
PhoneEmail
800 835 2263customerservice@acmeunited.com

Regulatory Flags#

DUNS number
001180207
Device count
1
DM exempt
false
Premarket exempt
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00738743210119First Aid Only21-01121-0112022-12-15
00738743961424Elite First Aid96142961422025-06-12
00738743961431Elite First Aid96143961432025-06-12
00738743007030First Aid OnlyM284-400M284-4002023-01-06
00092265912617First Aid Only91261912612023-07-21
00092265913898First Aid Only91389913892022-09-09
00092265913904First Aid Only91390913902022-09-09
00092265913911First Aid Only91391913912022-09-09
00092265913928First Aid Only91392913922022-09-09
00092265913935First Aid Only91393913932022-09-09
00092265913980First Aid Only91398913982022-09-09
00092265914024First Aid Only91402914022022-09-09
00092265914031First Aid Only91403914032022-09-09
00092265914048First Aid Only91404914042022-09-09
00092265914055First Aid Only91405914052022-09-09
00738743002608First Aid Only36693CV36693CV2022-09-09
00738743002721First Aid Only5011715011712022-09-09
00738743006507First Aid OnlyDX0401MDX0401M2022-09-09
00092265913256First Aid Only91325913252022-08-26
00092265913263First Aid Only91326913262022-08-26

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Primary DI, Brand, Company table
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