FDA.reportPublic FDA data

N/A

Primary DI
70885403251285
Brand
N/A
Company
Carefusion Finland 320 Oy
Model
M1024212
Catalog number
M1024212
Device description
Esophageal Stethoscope with Temperature Probe, Disposable, 12 Fr
Published
2016-09-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLLThermometer, electronic, clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
70885403251285PackageGS125Not in Commercial Distribution
10885403251283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
7088540325128570885403251285
1088540325128310885403251283

GMDN Terms#

Term, Definition table
TermDefinition
Electronic oesophageal stethoscope, single-useAn electronic listening device designed to be inserted into a patient's oesophagus to listen to heart and breathe sounds, typically while the patient is under anaesthesia. Some types may also have a temperature sensor to monitor the patient's temperature. The device will typically contain integral electrical conductors, thermistors/temperature sensors for proximal connection to a patient monitoring device, and include a proximal connector for a standard earpiece. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit95 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088gmb-MedSpec-CustService@carefusion.com

Regulatory Flags#

DUNS number
367919120
Device count
1
DM exempt
false
Premarket exempt
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403252051Multi-Link2052104-0052052104-0052016-09-14
10885403252068Multi-Link2052104-0062052104-0062016-09-14
10885403252075Multi-Link2052104-0072052104-0072016-09-14
10885403252082Multi-Link2052104-0082052104-0082016-09-14
10885403252112Multi-Link2052133-0052052133-0052016-09-14
10885403252129Multi-Link2052133-0062052133-0062016-09-14
10885403252136Multi-Link2052133-0072052133-0072016-09-14
10885403252143Multi-Link2052133-0082052133-0082016-09-14
10885403256837Multi-Link2086349-0032086349-0032016-09-14
10885403256844Multi-Link2086349-0042086349-0042016-09-14
10885403256875Multi-Link2086367-0032086367-0032016-09-14
10885403256882Multi-Link2086367-0042086367-0042016-09-14
10885403417436Multi-Link2052104-0272052104-0272016-09-14
10885403417450Multi-Link2052133-0272052133-0272016-09-14
10190752100015Multi-Link™2090101-0502090101-0502017-07-11
10190752100022Multi-Link™2090101-0602090101-0602017-07-11
10190752100046Multi-Link™2090101-0802090101-0802017-07-11
10190752100084Multi-Link™2090101-5112090101-5112017-07-11
10190752100107Multi-Link™2090101-5122090101-5122017-07-11
10190752100121Multi-Link™2090101-5132090101-5132017-07-11

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