FDA.reportPublic FDA data

Patient Application Kit for mature intact skin

Primary DI
17640121880961
Brand
Patient Application Kit for mature intact skin
Company
SenTec AG
Model
PAK-MI
Device description
A combination of single-use products intended to attach the Sentec sensors to conventional measurement sites, recommended for adult, pediatric and neonatal patients with mature/intact skin
Published
2021-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas AnesthesiaAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041548000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041548000SENTEC DIGITAL MONITOR MODEL #SDMSentec, Inc.2004-08-09LKD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17640121880961PackageGS112In Commercial Distribution
07640121880964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1764012188096117640121880961
07640121880964076401218809647640121880964

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous blood gas monitoring systemAn assembly of mains electricity (AC-powered) devices designed for the continuous and transcutaneous measurement of a patient's blood gas parameters, typically blood partial pressure of oxygen (pO2), blood partial pressure of carbon dioxide (pCO2), haemoglobin oxygen saturation (SpO2), and/or venous blood oxygenation through the jugular vein (SjvO2); often with pulse rate. It consists primarily of a probe for gas detection (e.g., via transcutaneous gas diffusion, or using light spectroscopy) placed on the patient’s skin, and an oximetry monitor for the measurement, analysis, and display of data; patient adhesives and connecting cables may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity25 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480797856
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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
07640121880902Isolation Transformer 100-120VRFT100VA-V12021-05-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05700693918808TCM 4 series ETX base unitRadiometer Medical ApSKLK2025-04-23
07640121880988103149 Calibration GasSenTec AGKLK2024-07-05
07640121880995103164 tCOM+SenTec AGKLK2024-07-05
07640121881008103420 Sensor Adapter Cable (Regular)SenTec AGKLK2024-07-05
07640121881015103421 Sensor Adapter Cable (Long)SenTec AGKLK2024-07-05
07640121881022103422 Sensor Adapter Cable (Extra Long)SenTec AGKLK2024-07-05
07640121881039Non-Adhesive WrapSenTec AGKLK2023-07-21
07640121880964Patient Application Kit for mature intact skinSenTec AGKLK2021-09-26
07640121880971Patient Application Kit for sensitive/fragile skinSenTec AGKLK2021-09-26
07640121880957Patient Application Kit with Ear Clip for mature/intact skinSenTec AGKLK2021-09-26
07640121880889SDM Water Protection CoverSenTec AGKLK2021-08-25
07640121880902Isolation Transformer 100-120VSenTec AGKLK2021-05-05
07640121880933Membrane Changer (single-use) / single unitSenTec AGKLK2021-02-28
07640121880810Ear Clip easySenTec AGKLK2020-03-31
07640121880858Contact Gel 2mlSenTec AGKLK2019-03-08
17640121880862Contact GelSenTec AGKLK2019-03-05
07640121880803Multi-Site Attachment Ring for fragile/sensitive skinSenTec AGKLK2019-01-29
07640121880797Multi-Site Attachment Ring for mature/intact skinSenTec AGKLK2019-01-29
00884838020849SO2 Optical ModulePhilips Medizin Systeme Böblingen GmbHKLK2018-12-18
07640121880315PSG-XSenTec AGKLK2018-11-12
07640121880612PSG Cable ASenTec AGKLK2018-11-12
07640121880629PSG Cable BSenTec AGKLK2018-11-12
07640121880636PSG Cable CSenTec AGKLK2018-11-12
07640121880643PSG Cable DSenTec AGKLK2018-11-12
07640121880650PSG Cable ESenTec AGKLK2018-11-12
07640121880667PSG Cable FSenTec AGKLK2018-11-12
07640121880674PSG Cable GSenTec AGKLK2018-11-12
07640121880681PSG Cable HSenTec AGKLK2018-11-12
07640121880698PSG Cable JSenTec AGKLK2018-11-12
07640121880704PSG Cable KSenTec AGKLK2018-11-12