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 - 04260167483276 Catalog Number :

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 - 04260167483481 Catalog Number : 957985

Device Description : Disposable pH Catheter, Dual Sensor, 21cm, LES Locator, VIID21

Device Class :

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 10

Versaflex - 04260167483740 Catalog Number : 900003

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

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

Versaflex - 04260167483757 Catalog Number : 900004

Device Description : Disposable pH / Impedance Catheter, Single pH Sensor, 7 Impedance Rings, Pediatr Disposable pH / Impedance Catheter, Single pH Sensor, 7 Impedance Rings, Pediatric, ZNIS+7R2.0

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

Versaflex - 04260167483764 Catalog Number : 900005

Device Description : Disposable pH / Impedance Catheter, Single pH Sensor, 7 Impedance Rings, Infant, Disposable pH / Impedance Catheter, Single pH Sensor, 7 Impedance Rings, Infant, ZNIS+7R1.5

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

Versaflex - 04260167483771 Catalog Number : 955901

Device Description : Disposable pH / Impedance Catheter, Single pH Sensor, 8 Impedance Rings, ZNIS+8R

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

Versaflex - 04260167483788 Catalog Number : 955907

Device Description : Disposable pH / Impedance Catheter, Single pH Sensor, 8 Impedance Rings, ZNIS+8R

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

Versaflex - 04260167483795 Catalog Number : 957900

Device Description : Disposable pH Catheter, Bifurcated Probe 1: Single, Probe 2: Single, VNIS+US

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

Versaflex - 04260167483818 Catalog Number : 957902

Device Description : Disposable pH Catheter, Bifurcated Probe 1: Single, Probe 2: Dual, 10cm, VNIS+UD10

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

Versaflex - 04260167483825 Catalog Number : 957914

Device Description : Disposable pH Catheter, Dual Sensor, 18cm, ENT, Large Diameter, VNID18/LD+ENT

Device Class : 1

Duns Number: 090073722

Premarket Exempt : Yes

Product Code : FFT

Prescription Use : Yes

Device Count : 1

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