FDA.reportPublic FDA data

SafetyO2

Primary DI
00817494020700
Brand
SafetyO2
Company
GROMAN INC.
Model
AM-OXY-FP
Device description
One SafetyO2 Kit Non-rebreather Oxygen Mask with FacePlate and Tubing
Published
2023-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Product Codes#

Code, Name table
CodeName
KGBMask, Oxygen, Non-Rebreathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGBMask, Oxygen, Non-RebreathingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817494020707PackageGS125In Commercial Distribution
20817494020704PackageGS150In Commercial Distribution
30817494020701PackageGS1100In Commercial Distribution
00817494020700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081749402070710817494020707
2081749402070420817494020704
3081749402070130817494020701
00817494020700008174940207008174940207000817494020700

GMDN Terms#

Term, Definition table
TermDefinition
Non-rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient's airway. It typically includes two unidirectional valves, one that closes during inspiration to prevent room air mixing with oxygen in a reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of soft, flexible polymers designed to create an airtight seal against the patient's face. It may include tubing, and various valves and connectors, however other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.

Regulatory Flags#

DUNS number
020124663
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817494020694SafetyNebAM-NEB-FP2023-03-01
10817494020691SafetyNebAM-NEB-FP2023-03-01
10817494020707SafetyO2AM-OXY-FP2023-03-01
20817494020254SafetyFiltaGRO-SF-NEB-25GRO-SF-NEB-252023-01-19
00817494020007EtchmasterEM-L-K-CAEM-L-K-CA2016-09-27
00817494020014EtchmasterEM-L-K-RBEM-L-K-RB2016-09-27
00817494020045EtchmasterEM-L-R-RBEM-L-R-RB2016-09-27
00817494020052EtchmasterEM-S-R-RBEM-S-R-RB2016-09-27
00817494020069EtchmasterEM-S-P-RBEM-S-P-RB2016-09-27
00817494020076EtchmasterEM-S-B-RBEM-S-B-RB2016-09-27
00817494020083EtchmasterEM-L-B-RBEM-L-B-RB2016-09-27
00817494020090EtchmasterEM-S-G-RBEM-S-G-RB2016-09-27
00817494020106EtchmasterEM-L-G-RBEM-L-G-RB2016-09-27
00817494020113EtchmasterEM-S-Y-RBEM-S-Y-RB2016-09-27
00817494020120EtchmasterEM-L-Y-RBEM-L-Y-RB2016-09-27
00817494020137EtchmasterEM-S-J-RBEM-S-J-RB2016-09-27
00817494020144EtchmasterEM-L-N-RBEM-L-N-RB2016-09-27
00817494020151EtchmasterEM-L-F-RBEM-L-F-RB2016-09-27
00817494020168EtchmasterEM-S-O-RBEM-S-O-RB2016-09-27
00817494020175EtchmasterPM-X-L-RBPM-X-L-RB2016-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09341394005242AeroShield CPR MaskAERO HEALTHCARE (US), LLCKGB2026-04-21
09341394027183AeroShield CPR Face ShieldAERO HEALTHCARE (US), LLCKGB2026-04-02
10197344009602HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344009619HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344011476HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344011483HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344011506HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344011810HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344042180HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344009609HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344009616HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344011473HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344011480HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344011503HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344011817HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344042187HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
008171360277227450 RV2 MASKHANS RUDOLPH, INC.KGB2025-10-16
07045432118124Pocket Mask, PB (DE FR ES IT EN)Laerdal Medical ASKGB2025-08-27
07045432118223Pocket Mask, SP Blue (DE FR ES IT EN)Laerdal Medical ASKGB2025-08-27
07045432119145Pocket Mask, HC Yellow (DE FR ES IT EN)Laerdal Medical ASKGB2025-08-27
07045432118131Pocket Mask, PB (EN)Laerdal Medical ASKGB2025-08-25
07045432119183Pocket Mask, HC White Private LabelLaerdal Medical ASKGB2025-08-25
07045432119206Pocket Mask, SP Black Private LabelLaerdal Medical ASKGB2025-08-25
07045432119220Pocket Mask, SP Camo Private LabelLaerdal Medical ASKGB2025-08-25
07045432119152Pocket Mask O2, PB (DE FR ES IT EN)Laerdal Medical ASKGB2025-07-29
07045432119169Pocket Mask O2, SP Blue (DE FR ES IT EN)Laerdal Medical ASKGB2025-07-29
07045432119176Pocket Mask O2,HC Yellow (DE FR ES IT EN)Laerdal Medical ASKGB2025-07-29
07045432119190Pocket Mask O2, HC White Private LabelLaerdal Medical ASKGB2025-07-29
07045432119213Pocket Mask O2, SP Black Private LabelLaerdal Medical ASKGB2025-07-29
07045432119237Pocket Mask O2, SP Camo Private LabelLaerdal Medical ASKGB2025-07-29