FDA.reportPublic FDA data

First Aid Only

Primary DI
00092265504256
Brand
First Aid Only
Company
Acme United Corporation
Model
730009
Catalog number
730009
Device description
Mask Face Shield, CPR Rescue
Published
2022-01-11
Public version status
Update
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
00092265504256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00092265504256000922655042560922655042560092265504256

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary resuscitation mouthpiece/coverA non-sterile device that consists of a mouthpiece with an integrated face/body covering sheet intended to be placed over a patient during cardiopulmonary resuscitation (CPR) to prevent cross-contamination between patient and CPR administrator; it may also include directions/positional markers printed on the cover intended to assist the administrator during CPR. The mouthpiece is designed to be used as a barrier during resuscitation (i.e., “mouth-to-mouthpiece”) as an alternative to conventional “mouth-to-mouth”. 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
Primary DIBrandCompanyProduct codePublished
08904461055024OSSEOUS-SnorOFFEON MEDITECH PRIVATE LIMITEDBYP2026-03-13
46923980103672N/AGaleMed Xiamen Co., Ltd.BYP2025-12-23
20197344011312HUDSON RCIMEDLINE INDUSTRIES, INC.BYP2025-08-18
04250892907321JaegerJaeger Medical GmbHBYP2025-06-02
04250892907383JaegerJaeger Medical GmbHBYP2025-06-02
30889483573451AirLife™Sunmed Group Holdings, LLCBYP2025-03-27
30889483569164AirLife™Sunmed Group Holdings, LLCBYP2025-03-18
30889483569195AirLife™Sunmed Group Holdings, LLCBYP2025-03-18
00817081028232Mouthpiece, Disposable, White, Thermoplastic, Bite Block StyleA-M SYSTEMS, LLCBYP2025-02-21
00817081028256Breathebite Mouthpiece, Disposable, Thermoplastic, Tongue DepressingA-M SYSTEMS, LLCBYP2025-02-21
14250892906833VyaireVyaire Medical GmbHBYP2025-01-07
14250892906840VyaireVyaire Medical GmbHBYP2025-01-07
14250892906857VyaireVyaire Medical GmbHBYP2025-01-07
14250892906864VyaireVyaire Medical GmbHBYP2025-01-07
07613365500110SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
07613365500134SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
07613365500196SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
00026072026304BFAllied Medical, LLCBYP2024-10-11
08052990320219MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABYP2024-09-10
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08052990321834MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABYP2024-09-10
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00026072026243BFAllied Medical, LLCBYP2024-05-28
00026072026298BFAllied Medical, LLCBYP2024-05-28
B279F037005001Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
B279F037020002Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
B279S29807005001Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
B279S29807020002Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
00817081027686Adapter, Tube, Sample PackA-M SYSTEMS, LLCBYP2023-11-21
10384620000730InFloConeALLIANCE TECH MEDICAL INCBYP2023-09-08