FDA.reportPublic FDA data

Reusable Temperature Probe

Primary DI
14251679601798
Brand
Reusable Temperature Probe
Company
BluePoint Medical GmbH & Co. KG
Model
Esophageal/Rectal, Adult
Catalog number
2107176-031
Device description
Probe for temperature measurement systems
Published
2021-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
14251679601798PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1425167960179814251679601798

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose patient temperature probe, reusableA 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 reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius50 Degrees Celsius
Storage Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+3581039411xx@xx.xx

Regulatory Flags#

DUNS number
507261522
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
24251679601511GE Healthcare Airway Gas Sampling Set Adult/Pediatric, 2m/7ft80901215212020-02-20
24251679601528GE Healthcare Airway Gas Sampling SetInfant, 2m/7ft80901215222020-02-20
24251679601535GE Healthcare Airway Gas Sampling SetAdult/Pediatric, 3m/10ft80901215312020-02-20
24251679601542GE Healthcare Airway AdapterAdult/Pediatric30901210022020-02-20
14251679601781Reusable Temperature ProbeEsophageal/Rectal, Pediatric2107176-0322021-12-10
14251679601804Reusable Temperature ProbeSkin, Adult2107176-0332021-12-10
04251679601517GE Healthcare Airway Gas Sampling Set Adult/Pediatric, 2m/7ft80901215212020-02-20
04251679601524GE Healthcare Airway Gas Sampling SetInfant, 2m/7ft80901215222020-02-20
04251679601531GE Healthcare Airway Gas Sampling SetAdult/Pediatric, 3m/10ft80901215312020-02-20
04251679601548GE Healthcare Airway AdapterAdult/Pediatric30901210022020-02-20

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