FDA.reportPublic FDA data

ENDURE INDUSTRIES

Primary DI
00840118611619
Brand
ENDURE INDUSTRIES
Company
ENDURE INDUSTRIES
Model
NROMPE11
Catalog number
NROMPE11
Device description
Non-Rebreathing Oxygen Mask, Pediatric, Elongated
Published
2024-04-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
00840118611626PackageGS140In Commercial Distribution
00840118620253PackageGS15In Commercial Distribution
00840118623520PackageGS1160In Commercial Distribution
00840118611619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840118611626008401186116268401186116260840118611626
00840118620253008401186202538401186202530840118620253
00840118623520008401186235208401186235200840118623520
00840118611619008401186116198401186116190840118611619

GMDN Terms#

Term, Definition table
TermDefinition
Aerosol face mask, non-rebreathingA flexible, form-shaped device that is placed over the nose and mouth to deliver air, oxygen (O2), or a mixture of the two gases, with aerosolized particles, to a patient's airway. It includes two unidirectional valves, one that closes during inspiration to prevent room air from mixing with the O2 in the reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of high-grade resins or other materials to produce a soft, flexible mask that will create an airtight seal against the patient's face. It typically includes a headstrap and is available in a range of sizes. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
6072994971support@endureind.com

Regulatory Flags#

DUNS number
066087031
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
00840118608046ENDURE INDUSTRIESNROMA11NROMA112024-04-01
00840118608060ENDURE INDUSTRIESNROMP11NROMP112024-04-10
00840118611633ENDURE INDUSTRIESNROMAE11NROMAE112024-04-01
00840118612791ENDURE INDUSTRIESA2001A20012023-10-15
00840118613958ENDURE INDUSTRIESNDAM211NDAM2112026-05-01
08697645018129ENDURE INDUSTRIESAMT4MAMT4M2026-04-17
08697645018136ENDURE INDUSTRIESAMT5M2026-04-17
08697645018143ENDURE INDUSTRIESAMT6MAMT6M2026-04-17
08697645018150ENDURE INDUSTRIESBGE7MBGE7M2026-04-17
08697645018167ENDURE INDUSTRIESBGE9MBGE9M2026-04-17
08697645018174ENDURE INDUSTRIESBGA7MBGA7M2026-04-17
08697645018181ENDURE INDUSTRIESBGA9M BGA9M 2026-04-17
08697645018198ENDURE INDUSTRIESBB1MBB1M2026-04-17
00840118603676EndureSLL1A3-0520SLL1A32021-04-06
00840118603706EndureSLL2A3-0520SLL2A32020-08-31
00840118603737EndureSLL3A3-0520SLL3A32021-07-25
00840118603768EndureSLL5A3-0520SLL5A32020-08-31
00840118603799EndureSLL10A3-0520SLL10A32020-08-31
00840118603829EndureSLL20A3-0520SLL20A32020-08-31
00840118603850EndureSLL50A3-0520SLL50A32020-08-31

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
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
07045432119855Pocket Mask O2,HC Yellow (EN)Laerdal Medical ASKGB2025-07-29
07045432119909Pocket Mask O2, PB (EN)Laerdal Medical ASKGB2025-07-29