FDA.report

Vital Signs

Primary DI
50885403288263
Brand
Vital Signs
Company
Carefusion Finland 320 Oy
Model
1011EU
Catalog number
1011EU
Device description
Vital Signs&#174 Disposable Esophageal Stethoscope with Temperature Probe, Non-Sterile, 18FR
Published
2016-09-23
Public version status
Update
Distribution status
Not 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
FLLThermometer, electronic, clinical

Product Code Classifications

CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50885403288263PackageGS150Not in Commercial Distribution
10885403288265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5088540328826350885403288263
1088540328826510885403288265

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius35 Degrees Celsius

Sterilization Methods

Method

Contacts

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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