FDA.reportPublic FDA data

Isolation Transformer 100-120V

Primary DI
07640121880902
Brand
Isolation Transformer 100-120V
Company
SenTec AG
Model
RFT100VA-V1
Device description
Isolates the SDM from mains for use in home use environments.
Published
2021-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DPZOximeter, Ear
DQAOximeter
KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
LKDMonitor, Carbon-Dioxide, Cutaneous
LPPMonitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPZOximeter, EarCardiovascular2
DQAOximeterCardiovascular2
KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas AnesthesiaAnesthesiology2
LKDMonitor, Carbon-Dioxide, CutaneousAnesthesiology2
LPPMonitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas AnesthesiaAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041548000
K071672000
K101690000
K151329000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041548000SENTEC DIGITAL MONITOR MODEL #SDMSentec, Inc.2004-08-09LKD
K071672000SENTEC DIGITAL MONITORING SYSTEMSentec AG2007-09-12DQA
K101690000SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLESentec AG2010-12-03LKD
K151329000SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNetSentec AG2015-12-17LKD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640121880902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640121880902076401218809027640121880902

GMDN Terms#

Term, Definition table
TermDefinition
Pulse Co-oximeter probe, reusableA photoelectric component of a pulse Co-oximeter that is applied externally to a body part (e.g., a fingertip for adults, the hand or foot for neonates), for the transcutaneous multiwave measurement of carboxy-haemoglobin saturation (SpCO) and typically several other related parameters such as haemoglobin oxygen saturation (SpO2), methaemoglobin saturation (SpMet), haemoglobin concentration (SpHb), haematocrit, and pulse rate using light detection. Signals from the probe, produced by a light-emitting diode (LED) and a receiving detector, are used to calculate results which are digitally displayed on the Co-oximeter's computerized unit. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480797856
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640121880803Multi-Site Attachment Ring for fragile/sensitive skinMARe-SF2019-01-29
07640121880810Ear Clip easyECe-MI2020-03-31
07640121880964Patient Application Kit for mature intact skinPAK-MI2021-09-26
07640121880971Patient Application Kit for sensitive/fragile skinPAK-SF2021-09-26
07640121881039Non-Adhesive Wrap1035202023-07-21
07640121880988103149 Calibration Gas1031492024-07-05
07640121880995103164 tCOM+1031642024-07-05
07640121881008103420 Sensor Adapter Cable (Regular)1034202024-07-05
07640121881015103421 Sensor Adapter Cable (Long)1034212024-07-05
07640121881022103422 Sensor Adapter Cable (Extra Long)1034222024-07-05
07640121880957Patient Application Kit with Ear Clip for mature/intact skinPAK-EC2021-09-26
07640121880889SDM Water Protection CoverSDM_WPC2021-08-25
07640121880933Membrane Changer (single-use) / single unitMC2021-02-28
17640121880862Contact GelGEL-SD2019-03-05
07640121880018Sentec Digital MonitorSDM2016-08-31
07640121880032Digital Sensor Adapter Cable, 150 cmAC-1502016-08-31
07640121880049Ear ClipEC-MI2016-08-31
07640121880056Service gasGAS-08122016-08-31
07640121880070Contact GelGEL-042016-08-31
07640121880087Membrane Changer (reloadable) / single unitMC-R2016-08-31

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