FDA.reportPublic FDA data

Isansys

Primary DI
05060488680045
Brand
Isansys
Company
ISANSYS LIFECARE LIMITED
Model
Lifetemp Sensor - V2 - Large
Catalog number
Lifetemp Sensor - V2 - Large
Device description
Continuous Clinical Thermometer
Published
2024-04-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172329000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172329000Patient Status EngineIsansys Lifecare, Ltd.2018-04-23DRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060488680045PackageGS110In Commercial Distribution
05060488680274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060488680045050604886800455060488680045
05060488680274050604886802745060488680274

GMDN Terms#

Term, Definition table
TermDefinition
Physiological measuring device wireless data capture/transfer unitA mobile electronic device/device assembly designed to be used by a healthcare professional (e.g., nurse, caregiver) to capture patient physiological parameters from wireless patient measuring devices (e.g., wireless pulse oximeter, wireless thermometer) during routine patient checks (e.g., as part of nursing rounds) and wirelessly send the information to the electronic health record. It is intended to capture and transfer patient identification and time/date with the physiological data; it will typically in addition allow for manual entry of data. It typically includes a display monitor, wireless receivers, and barcode reader.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
216707432
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
05060488680274IsansysLifetemp Sensor - V2 - LargeLifetemp Sensor - V2 - Large2024-04-26
05060488680281IsansysLifetemp Sensor - V2 - MediumLifetemp Sensor - V2 - Medium2024-04-26
05060488680298IsansysLifetemp Sensor - V2 - LargeLifetemp Sensor - V2 - Large2024-04-26
05060488680014IsansysLifetemp Sensor - SmallLifetemp Sensor - Small2024-04-26
05060488680021IsansysLifetemp Sensor - MediumLifetemp Sensor - Medium2024-04-26
05060488680038IsansysLifetemp Sensor - LargeLifetemp Sensor - Large2024-04-26
05060488680052IsansysLifetemp Sensor - V2 - MediumLifetemp Sensor - V2 - Medium2024-04-26
05060488680069IsansysLifetemp Sensor - V2 - LargeLifetemp Sensor - V2 - Large2024-04-26
05060488680090IsansysLifetouch Sensor - SmallLifetouch Sensor - Small2024-04-25
05060488680106IsansysLifetouch Sensor - MediumLifetouch Sensor - Medium2024-04-25
05060488680113IsansysLifetouch Sensor - LargeLifetouch Sensor - Large2024-04-25
05060488680144IsansysLifetouch Sensor - SmallLifetouch Sensor - Small2024-04-25
05060488680151IsansysLifetouch Sensor - MediumLifetouch Sensor - Medium2024-04-25
05060488680168IsansysLifetouch Sensor - LargeLifetouch Sensor - Large2024-04-25
05060488680175IsansysLifeguard ServerLifeguard Server2024-04-25
05060488680182IsansysPatient Gateway T580 - 10.1 - WiFiGateway T580 - 10.1 - WiFi2024-04-25
05060488680205IsansysPatient Gateway T580 - 10.1 - GSMPatient Gateway T580 - 10.1 - GSM2024-04-25
05060488680250IsansysPatient Gateway T510 - 10.1 - WiFi Gateway T510 - 10.1 - WiFi2024-04-25
05060488680267IsansysPatient Gateway T515 - 10.1 - GSM Gateway T515 - 10.1 - GSM2024-04-25
05060488680304IsansysPatient Gateway SM-X200 – 10.5 - WiFiGateway SM-X200 – 10.5 - WiFi2024-04-25

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Primary DI, Brand, Company table
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04719875011030EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
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B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
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00198953030981PORTRAIT HSWXBGE Healthcare Finland OyDRG2025-12-10
B353UB12511UbiqVue HolterLifesignals, Inc.DRG2025-04-22
B353UB22511UbiqVue HolterLifesignals, Inc.DRG2025-04-22