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 - 04260167483955 Catalog Number : 957972

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

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

Versaflex - 04260167483962 Catalog Number : 957973

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

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

Versaflex - 04260167483979 Catalog Number : 957974

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

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

Versaflex - 04260167483986 Catalog Number : 957975

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

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

Versaflex - 04260167483993 Catalog Number : 957976

Device Description : Disposable pH Catheter, Dual Sensor, 7.5cm, VNID7.5

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

Versaflex - 04260167484013 Catalog Number : 957978

Device Description : Disposable pH Catheter, Triple Sensor, XX and XXcm, VNITXX

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

Versaflex - 04260167484037 Catalog Number : 957980

Device Description : Disposable pH Catheter, Single Sensor, LES Locator, VIIS

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

Versaflex - 04260167484068 Catalog Number : 957983

Device Description : Disposable pH Catheter, Dual Sensor, 15cm, LES Locator, VIID15

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

Versaflex - 04260167484099 Catalog Number :

Device Description : Disposable pH / Impedance Catheter, Dual pH Sensor, 12cm, 8 Impedance Rings, LPR ZNID12+8R

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

Versaflex - 04260167484105 Catalog Number :

Device Description : Disposable pH / Impedance Catheter, Dual pH Sensor, 15cm, 8 Impedance Rings, LPR ZNID15+8R

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

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