FDA.report

RUSCH

Primary DI
24026704657203
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN913998
Catalog number
395497
Device description
Infant Oxygen Mask High Concentration Non-Rebreathing With 7 ft. Oxygen Tubing
Published
2019-05-09
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

Related Records

Contact Domains

Product Codes

CodeName
KGBMASK, OXYGEN, NON-REBREATHING

Product Code Classifications

CodeDeviceSpecialtyClass
KGBMask, Oxygen, Non-RebreathingAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
24026704657203PackageGS150In Commercial Distribution
04026704543274PreviousGS10
14026704657206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
2402670465720324026704657203
04026704543274040267045432744026704543274
1402670465720614026704657206

GMDN Terms

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

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
Device count
1
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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