FDA.report

Breathing hose for Resuscitaire with AutoBreath, d

Primary DI
04049098000406
Brand
Breathing hose for Resuscitaire with AutoBreath, d
Company
DRAEGER MEDICAL SYSTEMS, INC.
Model
MU10841
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
FMTWarmer, Infant Radiant

Product Code Classifications

CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1
FMTWarmer, Infant RadiantGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049098000406PrimaryGS10
04049098058032Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049098000406040490980004064049098000406
04049098058032040490980580324049098058032

GMDN Terms

TermDefinition
General-purpose patient temperature probe, single-useA temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+18004372437info@draeger.com

Regulatory Flags

DUNS number
788289952
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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