FDA.report

Adsafe™

Primary DI
00634782558024
Brand
Adsafe™
Company
AMERICAN DIAGNOSTIC CORP
Model
4056ORQ
Catalog number
4056ORQ
Device description
ADSAFE Face Shield Plus,Adult, w/keychain,Orange,Disp
Published
2016-09-21
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
false

Related Records

Contact Domains

Product Codes

CodeName
BYGMask, Oxygen

Product Code Classifications

CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00634782558024PackageGS14In Commercial Distribution
00634782858025PackageGS112In Commercial Distribution
00634782058241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782558024006347825580246347825580240634782558024
00634782858025006347828580256347828580250634782858025
00634782058241006347820582416347820582410634782058241

GMDN Terms

TermDefinition
Cardiopulmonary resuscitation mask, reusableA 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). This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-232-2670info@adctoday.com

Regulatory Flags

DUNS number
108999095
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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 DIBrandModelCatalogPublished
00634782902636Adcuff™ 920-011N920-011N2026-02-23
00634782101695ADC®381N381N2026-02-20
00634782903213ADC®380N380N2026-02-20
00634782903190Advantage™611561152025-11-24
00634782903152Advantage™611261122025-09-19
00634782903169Advantage™612161212025-09-19
00634782903176Advantage™6121SA6121SA2025-09-19
00634782903183Advantage™6121X6121X2025-09-19
00634782903091Adtemp™ 424N-40424N-402025-02-05
00634782603106Adtemp™ 424N-200424N-2002025-02-05
00634782903039Adtemp™ 424N424N2025-01-29
00634782600402Adscope®608LPST608LPST2023-01-11
00634782600600Adscope®600IMCA600IMCA2023-01-10
00634782600617Adscope®600IST600IST2023-01-10
00634782600624Adscope®601IMCA601IMCA2023-01-10
00634782600631Adscope®601IST601IST2023-01-10
00634782600648Adscope®601RGBK601RGBK2023-01-10
00634782600655Adscope®608RGBK608RGBK2023-01-10
00634782600662Adscope®608RGW608RGW2023-01-10
00634782600679Adscope®606RGBK606RGBK2023-01-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07045432120462Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
07045432120479Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
07045432120486Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
07045432120493Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
07045432120509Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
20885632467407HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
20885632467414HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
20885632467469HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
07045432115987The BAG Mask size 1Laerdal Medical ASBYG2026-01-14
07045432115994The BAG Mask size 2 Laerdal Medical ASBYG2026-01-14
07045432116007The BAG Mask size 3 Laerdal Medical ASBYG2026-01-14
07045432116014The BAG Mask size 4Laerdal Medical ASBYG2026-01-14
07045432116021The BAG Mask size 5Laerdal Medical ASBYG2026-01-14
20889483221669Performance Home MedicalSUNMED, LLCBYG2025-12-31
20889483227265BiFLo™SUNMED, LLCBYG2025-12-30
20889483227272BiFLo™SUNMED, LLCBYG2025-12-30
20889483223977AirLife™SUNMED, LLCBYG2025-12-19
20889483224158AirLife™SUNMED, LLCBYG2025-12-19
20889483224295DeVilbissSUNMED, LLCBYG2025-12-19
20889483224684AirLife™SUNMED, LLCBYG2025-12-19
20889483224165AirLife™SUNMED, LLCBYG2025-12-18
20197344011114HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
20197344011749HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
20197344011756HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
20197344011770HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
20197344042200HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
B0026300RescuerB.L.S. Systems LimitedBYG2025-11-24
B00263050RescuerB.L.S. Systems LimitedBYG2025-11-24
20197344011589HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
20197344011596HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14