FDA.reportPublic FDA data

RUSCH

Primary DI
24026704543247
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN044313
Catalog number
395406
Device description
Infant Oxygen Mask High Concentration Rebreathing
Published
2020-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
24026704543247PackageGS150Not in Commercial Distribution
04026704543243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670454324724026704543247
04026704543243040267045432434026704543243

GMDN Terms#

Term, Definition table
TermDefinition
Partial-rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It includes a reservoir bag used for inhaling a mixture of exhaled and fresh gases. It is made of non-conductive, soft, flexible polymers available in a range of sizes, designed to create an airtight seal against the patient's face and may also include tubing, and various valves and connectors; other equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
008171360277157450 RV2 MASKHANS RUDOLPH, INC.KGB2025-09-19
07045432118179Pocket Mask, PB (DE FR ES IT EN)Laerdal Medical ASKGB2025-08-27
07045432118285Pocket Mask, SP Blue (DE FR ES IT EN)Laerdal Medical ASKGB2025-08-27
07045432119244Pocket Mask, HC Yellow (DE FR ES IT EN)Laerdal Medical ASKGB2025-08-27
07045432118186Pocket Mask, PB (EN)Laerdal Medical ASKGB2025-08-25
07045432118230Pocket Mask, SP Blue (EN)Laerdal Medical ASKGB2025-08-25
07045432119282Pocket Mask, HC White Private LabelLaerdal Medical ASKGB2025-08-25
07045432119305Pocket Mask, SP Black Private LabelLaerdal Medical ASKGB2025-08-25
07045432119329Pocket Mask, SP Camo Private LabelLaerdal Medical ASKGB2025-08-25
07045432119770Pocket Mask, HC Yellow (EN)Laerdal Medical ASKGB2025-08-25
07045432119251Pocket Mask O2, PB (DE FR ES IT EN)Laerdal Medical ASKGB2025-07-29
07045432119268Pocket Mask O2, SP Blue (DE FR ES IT EN)Laerdal Medical ASKGB2025-07-29
07045432119275Pocket Mask O2,HC Yellow (DE FR ES IT EN)Laerdal Medical ASKGB2025-07-29
07045432119299Pocket Mask O2, HC White Private LabelLaerdal Medical ASKGB2025-07-29
07045432119312Pocket Mask O2, SP Black Private LabelLaerdal Medical ASKGB2025-07-29
07045432119336Pocket Mask O2, SP Camo Private LabelLaerdal Medical ASKGB2025-07-29
07045432119879Pocket Mask O2,HC Yellow (EN)Laerdal Medical ASKGB2025-07-29
07045432119947Pocket Mask O2, PB (EN)Laerdal Medical ASKGB2025-07-29
07045432120004Pocket Mask O2, SP Blue (EN)Laerdal Medical ASKGB2025-07-29
00840117345232Resp-O2 Non-Rebreather Elongated Mask, Pediatric, With Safety Vent, 7' (2.1m) Dynarex CorporationKGB2025-05-30
00840117345249Resp-O2 Non-Rebreather Elongated Mask, Adult, 7' (2.1m) Crush-Resistant Tubing Dynarex CorporationKGB2025-05-30
00840117345256Resp-O2 Non-Rebreather Elongated Mask, Pediatric, 7' (2.1m) Crush-Resistant Dynarex CorporationKGB2025-05-30
00840117345263Resp-O2 Non-Rebreather Elongated Mask, Infant 7' (2.1m) Crush-Resistant Tubing Dynarex CorporationKGB2025-05-30