FDA.reportPublic FDA data

Resp-O2 Non-Rebreather Elongated Mask, Pediatric, With Safety Vent, 7' (2.1m)

Primary DI
00840117345232
Brand
Resp-O2 Non-Rebreather Elongated Mask, Pediatric, With Safety Vent, 7' (2.1m)
Company
Dynarex Corporation
Model
33051U
Device description
Crush-Resistant Tubing 600 mL, Reservoir Bag, Universal Connector
Published
2025-05-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00840117345171PackageGS150In Commercial Distribution
00840117345232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117345171008401173451718401173451710840117345171
00840117345232008401173452328401173452320840117345232

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117309210Resp-O2 Suction Tubing Combo Pack, Non-Sterile321002021-04-22
00840117309234Resp-O2 Suction Connecting Tubing, Non-Conductive321032021-04-22
00840117309258Resp-O2 Suction Connecting Tubing, Non-Conductive321042021-04-22
00840117309272Resp-O2 Suction Connecting Tubing, Non-Conductive321062021-04-22
00840117309296Resp-O2 Suction Connecting Tubing, Non-Conductive321072021-04-22
00840117309371Resp-O2 Suction Connecting Tubing, Non-Conductive321112021-04-22
00840117309395Resp-O2 Suction Connecting Tubing, Non-Conductive321122021-04-22
00840117313651Resp-O2 Suction Connecting Tubing, Non-Conductive321052021-04-22
00840117309418Resp-O2 Yankauer Suction Handle, Bulb Tip, Vented,321202022-05-10
00840117309432Resp-O2 Yankauer Suction Handle, Bulb Tip, Non-Vented321212022-05-10
00840117309456Resp-O2 Yankauer Suction Handle, Straight Tip, Vented321222022-05-10
00840117309319Resp-O2 Suction Connecting Tubing, Non-Conductive321082022-05-09
00840117309326Resp-O2 Suction Connecting Tubing, Non-Conductive321092022-05-09
00840117309357Resp-O2 Suction Connecting Tubing, Non-Conductive321102022-05-09
00840117309494Resp-O2 Yankauer Suction Handle, Bulb Tip, Non-Vented321262022-05-09
00840117309470Resp-O2 Yankauer Suction Handle, Straight Tip, Non-Vented321232022-04-21
00840117313675Resp-O2 Yankauer Suction Handles, Bulb Tip, Non-Vented321252022-04-21
00840117313699Resp-O2 Yankauer Suction Handle, Bulb Tip, Non-Vented321272022-04-21
00840117313712Resp-O2 Yankauer Suction Handle, Bulb Tip, Non-Vented321282022-04-21
00840117321748Resp-O2 Suction Connecting Tubing, Non-Sterile321012022-04-21

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
008171360277227450 RV2 MASKHANS RUDOLPH, INC.KGB2025-10-16
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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
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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
07045432119978Pocket Mask O2, SP Blue (EN)Laerdal Medical ASKGB2025-07-29