FDA.reportPublic FDA data

Multi-Site Attachment Ring for fragile/sensitive s

Primary DI
17640121880800
Brand
Multi-Site Attachment Ring for fragile/sensitive s
Company
SenTec AG
Model
MARe-SF
Device description
Single use sensor application ring, recommended for adult, pediatric and neonatal patients with sensitive/fragile skin
Published
2019-01-29
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
LPPMonitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPPMonitor, Oxygen, Cutaneous, For Uses Other Than 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
17640121880800PackageGS124In Commercial Distribution
07640121880803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1764012188080017640121880800
07640121880803076401218808037640121880803

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
Special Storage Condition, Specify00Temperature during transport: 0-50°C
Storage Environment Humidity25 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius27 Degrees Celsius
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480797856
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
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 ApSLPP2025-04-23
07640121880988103149 Calibration GasSenTec AGLPP2024-07-05
07640121880995103164 tCOM+SenTec AGLPP2024-07-05
07640121881008103420 Sensor Adapter Cable (Regular)SenTec AGLPP2024-07-05
07640121881015103421 Sensor Adapter Cable (Long)SenTec AGLPP2024-07-05
07640121881022103422 Sensor Adapter Cable (Extra Long)SenTec AGLPP2024-07-05
07640121881039Non-Adhesive WrapSenTec AGLPP2023-07-21
07332834000790PF 6840-1 TC Remote Panel 1 ChannelPerimed ABLPP2023-02-01
07332834000806PF 6840-2 TC Remote Panel 2 ChannelsPerimed ABLPP2023-02-01
07332834000820PF 6840-4 TC Remote Panel 4 ChannelsPerimed ABLPP2023-02-01
07640121880964Patient Application Kit for mature intact skinSenTec AGLPP2021-09-26
07640121880971Patient Application Kit for sensitive/fragile skinSenTec AGLPP2021-09-26
07640121880957Patient Application Kit with Ear Clip for mature/intact skinSenTec AGLPP2021-09-26
07640121880889SDM Water Protection CoverSenTec AGLPP2021-08-25
07640121880902Isolation Transformer 100-120VSenTec AGLPP2021-05-05
07640121880933Membrane Changer (single-use) / single unitSenTec AGLPP2021-02-28
07640121880810Ear Clip easySenTec AGLPP2020-03-31
17640121880817Ear Clip easySenTec AGLPP2020-03-31
07640121880858Contact Gel 2mlSenTec AGLPP2019-03-08
17640121880862Contact GelSenTec AGLPP2019-03-05
07640121880803Multi-Site Attachment Ring for fragile/sensitive skinSenTec AGLPP2019-01-29
07640121880797Multi-Site Attachment Ring for mature/intact skinSenTec AGLPP2019-01-29
07640121880315PSG-XSenTec AGLPP2018-11-12
07640121880612PSG Cable ASenTec AGLPP2018-11-12
07640121880629PSG Cable BSenTec AGLPP2018-11-12
07640121880636PSG Cable CSenTec AGLPP2018-11-12
07640121880643PSG Cable DSenTec AGLPP2018-11-12
07640121880650PSG Cable ESenTec AGLPP2018-11-12
07640121880667PSG Cable FSenTec AGLPP2018-11-12
07640121880674PSG Cable GSenTec AGLPP2018-11-12