FDA.reportPublic FDA data

Skin Probe, Medium, Schiller

Primary DI
04260651380296
Brand
Skin Probe, Medium, Schiller
Company
Sensatronic GmbH
Model
SPR-300S1
Catalog number
2.101103
Device description
Reusable temperature probe, Skin application, medium, Schiller AG branded
Published
2021-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203643000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203643000Sensatronic Reusable Temperature ProbesSensatronic GmbH2021-08-11FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260651380296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260651380296042606513802964260651380296

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3Meter

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

Regulatory Flags#

DUNS number
331950332
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
04260651380197General Purpose Rectal/Esophageal Probe, LargeAR-275PRA011-001192023-11-10
04260651380203General Purpose Rectal/Esophageal Probe, MediumPR-275PRA011-001202023-11-10
04260651380210General Purpose Rectal/Esophageal Probe, SmallNR-275PRA011-001212023-11-10
04260651380227Skin Probe, LargeSAR-275PRA011-001222023-11-10
04260651380234Skin Probe, MediumSPR-275PRA011-001232023-11-10
04260651380241Skin Probe, SmallSNR-275PRA011-001242023-11-10
04260651380012General Purpose Rectal/Esophageal Probe, LargeAR-275PA011-001012022-08-31
04260651380029General Purpose Rectal/Esophageal Probe, MediumPR-275PA011-001022022-08-31
04260651380036General Purpose Rectal/Esophageal Probe, SmallNR-275PA011-001032022-08-31
04260651380043Skin Probe, LargeSAR-275PA011-001042022-08-31
04260651380050Skin Probe, MediumSPR-275PA011-001052022-08-31
04260651380067Skin Probe, SmallSNR-275PA011-001062022-08-31
04260651380265General Purpose Rectal/Esophageal Probe, Large, SchillerAR-300S12.1010932021-12-01
04260651380272General Purpose Rectal/Esophageal Probe, Medium, SchillerPR-300S12.1010942021-12-01
04260651380289Skin Probe, Large, SchillerSAR-300S12.1010952021-12-01
04260651380302General Purpose Rectal/Esophageal Probe, Medium, SchillerPR-500S12.1011062021-12-01
04260651380319General Purpose Rectal/Esophageal Probe, Large, SchillerAR-500S12.1011072021-12-01
04260651380326Skin Probe, Small, SchillerSNR-300S12.1011102021-12-01
04260651380333Skin Probe, Large, SchillerSAR-500S12.1011412021-12-01
04260651380340Skin Probe, Medium, SchillerSPR-500S12.1011402021-12-01

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