FDA.report

Mask face tent O2Star S

Primary DI
04048675382508
Brand
Mask face tent O2Star S
Company
Drägerwerk AG & Co. KGaA
Model
MP01933
Published
2015-10-24
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

Related Records

Contact Domains

Product Codes

CodeName
CATCannula, Nasal, Oxygen

Product Code Classifications

CodeDeviceSpecialtyClass
CATCannula, Nasal, OxygenAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048675382508PrimaryGS10
04048675420507Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048675382508040486753825084048675382508
04048675420507040486754205074048675420507

GMDN Terms

TermDefinition
Oxygen administration tent, adultA flexible enclosure designed for the top of a bed that is used to cover the head/torso of an adult patient to provide an enriched oxygen (O2) environment to increase the patient's O2 uptake. It is connected to an O2 source and may be used concurrently with increased humidification and temperature control. It typically consists of a metal frame covered with transparent plastic, tubing, and may have built-in humidification. It is used for the treatment of breathing and other cardiopulmonary disorders, and for patients who are adverse to oxygen delivery devices such as a nasal cannula, face mask or endotracheal (ET) tube. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+494518820info@draeger.com

Regulatory Flags

DUNS number
315578914
Device count
50
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
false
Sterilization required before use
false

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04048675557739IBP Adapter Cable Drager 10pin26075592026-01-06
04048675428909ThermoTrace_Peripheral_5pcsMX110012015-10-24
04048675428916ThermoTrace Core (5pcs)MX110002015-10-24

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