FDA.reportPublic FDA data

N/A

Primary DI
06923980102776
Brand
N/A
Company
GaleMed Xiamen Co., Ltd.
Model
AO0093
Device description
OM-2 HiO2 Mask, Adult w/Tubing, PVC Bag
Published
2026-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
46923980102774PackageGS150In Commercial Distribution
06923980102776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4692398010277446923980102774
06923980102776069239801027766923980102776

GMDN Terms#

Term, Definition table
TermDefinition
Vortex oxygen face maskA non-sterile, form-shaped, fenestrated device designed to be placed over the nose and mouth to deliver a near-precise mixture of air and oxygen (O2) to a patient's airway without the use of a gas mixer. It incorporates a pin/diffuser intended to create vortices of high-concentration O2 directed to the mouth and nose to provide the full range of FiO2 (fraction of inspired oxygen) required for oxygen therapy. The fenestration designed to prevent positive pressure build-up and rebreathing, also allows for easier communication/feeding. It may include tubing, and various valves and connectors, however other respiratory equipment (e.g., nebulizer) is not included. This is a single-use device.

Regulatory Flags#

DUNS number
527333326
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
true
Expiration date on label
true
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
06923980102783N/AAO00942026-09-22
06923980106026N/AAO00922026-09-22
06923980116179N/AAB05092026-08-19
06923980116186N/AAB05102026-08-19
06923980116193N/AAB05112026-08-19
06923980116209N/AAB05122026-08-19
06923980101922N/AAW0005AW00052023-08-16
06923980101939N/AAW0006AW00062023-08-16
06923980102028N/AAW0007AW00072023-08-16
06923980103629N/AAC01352026-07-28
06923980107672N/AAC01422026-07-28
06923980111969N/AAC01602026-07-28
06923980111907MindrayXMR00512026-05-26
06923980112546MindrayXMR00662026-05-26
06923980112577MindrayXMR00242026-05-26
06923980112584MindrayXMR00262026-05-26
06923980112591MindrayXMR01012026-05-26
06923980112607MindrayXMR01022026-05-26
06923980112614MindrayXMR00522026-05-26
06923980112621MindrayXMR00532026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06923980102783N/AGaleMed Xiamen Co., Ltd.KGB2026-09-22
06923980106026N/AGaleMed Xiamen Co., Ltd.KGB2026-09-22
04719874950989Create BiotechCREATE BIOTECH CO., LTD.KGB2026-07-21
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
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
00840117345232Resp-O2 O2 Non-Rebreather Elongated MaskDynarex CorporationKGB2025-05-30
00840117345249Resp-O2 O2 Non-Rebreather Elongated MaskDynarex CorporationKGB2025-05-30
00840117345256Resp-O2 O2 Non-Rebreather Elongated MaskDynarex CorporationKGB2025-05-30
00840117345263Resp-O2 O2 Non-Rebreather Standard MaskDynarex CorporationKGB2025-05-30