Versaflex FGS-9000-18

GUDID 04260167483412

Disposable pH / Impedance Catheter, Dual pH Sensor, 19cm, 8 Impedance Rings, LPR ZNID19+8R

Given Imaging, Inc.

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• Primary Device ID: 04260167483412
• NIH Device Record Key: 2000b1ee-3983-4c12-b5d9-06f12e700b54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Versaflex
• Version Model Number: FGS-9000-18
• Catalog Number: FGS-9000-18
• Company DUNS: 090073722
• Company Name: Given Imaging, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Fragile

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260167483412 [Package]; Contains: 04260167484112; Package: CASE [10 Units]; In Commercial Distribution
GS1	04260167484112 [Primary]

FDA Product Code

• FFT: Electrode, pH, stomach

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-08-29

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• 04260167483429: Disposable pH / Impedance Catheter, Dual pH Sensor, 22cm, 8 Impedance Rings, LPR ZNID22+8R
• 04260167483412: Disposable pH / Impedance Catheter, Dual pH Sensor, 19cm, 8 Impedance Rings, LPR ZNID19+8R
• 04260167483405: Disposable pH / Impedance Catheter, Dual pH Sensor, 15cm, 8 Impedance Rings, LPR ZNID15+8R
• 04260167483399: Disposable pH / Impedance Catheter, Dual pH Sensor, 12cm, 8 Impedance Rings, LPR ZNID12+8R
• 04260167481500: Disposable pH Catheter, Dual Sensor, 15cm, LES Locator, VIID15
• 04260167484037: Disposable pH Catheter, Single Sensor, LES Locator, VIIS
• 04260167481463: Disposable pH Catheter, Triple Sensor, XX and XXcm, VNITXX
• 04260167481449: Disposable pH Catheter, Dual Sensor, 7.5cm, VNID7.5
• 04260167481432: Disposable pH Catheter, Dual Sensor, 21cm, VNID21
• 04260167481425: Disposable pH Catheter, Dual Sensor, 18cm, VNID18
• 04260167481418: Disposable pH Catheter, Dual Sensor, 15cm, VNID15
• 04260167481401: Disposable pH Catheter, Dual Sensor, 10cm, VNID10
• 04260167481395: Disposable pH Catheter, Dual Sensor, 5cm, VNID05
• 04260167481388: Disposable pH Catheter, Single Sensor, VNIS
• 04260167481364: Disposable pH Catheter, Dual Sensor, 15cm, Large Diameter, VNID15/LD
• 04260167481357: Disposable pH Catheter, Dual Sensor, 10cm, Large Diameter, VNID10/LD
• 04260167481340: Disposable pH Catheter, Dual Sensor, 5cm, Large Diameter, VNID05/LD
• 04260167481333: Disposable pH Catheter, Single Sensor, Large Diameter, VNIS/LD
• 04260167481326: Disposable pH Catheter, Dual Sensor, 21cm, ENT, VNID21+ENT
• 04260167481319: Disposable pH Catheter, Dual Sensor, 18cm, ENT, VNID18+ENT
• 04260167481302: Disposable pH Catheter, Dual Sensor, 15cm, ENT, VNID15+ENT
• 04260167481296: Disposable pH Catheter, Dual Sensor, 10cm, ENT, VNID10+ENT
• 04260167483559: Disposable pH Catheter, Dual Sensor, 18cm, ENT, Large Diameter, VNID18/LD+ENT
• 04260167483535: Disposable pH Catheter, Bifurcated Probe 1: Single, Probe 2: Dual, 10cm, VNIS+UD10
• 04260167481289: Disposable pH Catheter, Bifurcated Probe 1: Single, Probe 2: Single, VNIS+US
• 04260167483566: Disposable pH / Impedance Catheter, Single pH Sensor, 8 Impedance Rings, ZNIS+8R
• 04260167481173: Disposable pH / Impedance Catheter, Single pH Sensor, 8 Impedance Rings, ZNIS+8R
• 04260167482330: Disposable pH / Impedance Catheter, Single pH Sensor, 7 Impedance Rings, Infant, ZNIS+7R1.5
• 04260167482323: Disposable pH / Impedance Catheter, Single pH Sensor, 7 Impedance Rings, Pediatric, ZNIS+7R2.0
• 04260167482316: Disposable pH / Impedence Catheter, Dual pH Sensor, 15cm, 8 Impedance Rings, ZNID15+8R
• 04260167483481: Disposable pH Catheter, Dual Sensor, 21cm, LES Locator, VIID21
• 04260167483276: Disposable pH Catheter, Single Sensor, VNIS
• 04260167483184: Disposable pH / Impedance Catheter, Single pH Sensor, 8 Impedance Rings, ZNIS+8R