Given Imaging, Inc.

Address:15 Hampshire Street,Mansfield,MA,02048,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Electrode, pH, stomach (FFT) (10)

Premarket Exempt

No Yes

Clear

Versaflex - 04260167483832 Catalog Number : 957922

Device Description : Disposable pH Catheter, Dual Sensor, 10cm, ENT, VNID10+ENT

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

Versaflex - 04260167483849 Catalog Number : 957923

Device Description : Disposable pH Catheter, Dual Sensor, 15cm, ENT, VNID15+ENT

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

Versaflex - 04260167483856 Catalog Number : 957924

Device Description : Disposable pH Catheter, Dual Sensor, 18cm, ENT, VNID18+ENT

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

Versaflex - 04260167483863 Catalog Number : 957925

Device Description : Disposable pH Catheter, Dual Sensor, 21cm, ENT, VNID21+ENT

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

Versaflex - 04260167483870 Catalog Number : 957930

Device Description : Disposable pH Catheter, Single Sensor, Large Diameter, VNIS/LD

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

Versaflex - 04260167483887 Catalog Number : 957931

Device Description : Disposable pH Catheter, Dual Sensor, 5cm, Large Diameter, VNID05/LD

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

Versaflex - 04260167483894 Catalog Number : 957932

Device Description : Disposable pH Catheter, Dual Sensor, 10cm, Large Diameter, VNID10/LD

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

Versaflex - 04260167483900 Catalog Number : 957933

Device Description : Disposable pH Catheter, Dual Sensor, 15cm, Large Diameter, VNID15/LD

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

Versaflex - 04260167483931 Catalog Number : 957970

Device Description : Disposable pH Catheter, Single Sensor, VNIS

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

Versaflex - 04260167483948 Catalog Number : 957971

Device Description : Disposable pH Catheter, Dual Sensor, 5cm, VNID05

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

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