Diversatek Healthcare ZPN-BG-57

GUDID 00816734022726

Non-Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal)

DIVERSATEK HEALTHCARE, INC.

Oesophageal motility analysis system Oesophageal motility analysis system Oesophageal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system

• Primary Device ID: 00816734022726
• NIH Device Record Key: 3e356cb4-9a8b-4fac-b8ef-57e3ed8218b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diversatek Healthcare
• Version Model Number: ZPN-BG-57
• Catalog Number: ZPN-BG-57
• Company DUNS: 030650113
• Company Name: DIVERSATEK HEALTHCARE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com

Device Dimensions

• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French
• Catheter Gauge: 6.4 French

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816734022726 [Primary]
HIBCC	B019ZPNBG570 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012232

FDA Product Code

• FFT: Electrode, Ph, Stomach
• FFX: System, Gastrointestinal Motility (Electrical)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-10
• Device Publish Date: 2019-10-02

On-Brand Devices [Diversatek Healthcare]

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• M7831201481: Basic Endoscopy Procedure Kit
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• M7831201961: Basic Endoscopy Procedure Kit
• M78312011001: Basic Endoscopy Procedure Kit
• 00816734023341: ZepHr Pack
• 00816734022412: Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal)
• 00816734022405: Non-Infused Single-Use Z/pH Probe (External Reference), Single pH (Esophageal)
• 00816734022399: Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal)
• 00816734022382: Non-Infused Single-Use Z/pH Probe (External Reference), Dual pH (Gastric & Esophageal)
• 00816734022375: Non-Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal)
• 00816734022368: Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) with LES Locator, Loc
• 00816734022351: Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal), Locator Po
• 00816734022344: Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal)
• 00816734022337: Non-Infused Single-Use Z/pH Probe (External Reference), Single pH (Esophageal)
• 00816734022320: Non-Infused Single-Use Z/pH Probe (Internal Reference), Triple Sensor
• 00816734022313: Single-Use Z/pH Probe (External Reference), Single pH (Esophageal)
• 00816734022306: Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal)
• 00816734022290: Single-Use Z/pH Probe (External Reference), Dual pH (Gastric & Esophageal)
• 00816734022283: Non-Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric & Esophageal)
• 00816734022276: Non-Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Esophageal)
• 00816734022269: Single-Use Z/pH Probe (External Reference), Single pH (Esophageal) with LES Locator, Locator Por
• 00816734022252: Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) with LES Locator, Loc
• 00816734022245: LPR Probe, Dual pH (Esophageal), LPR Acid, Locator Port 6cm
• 00816734022238: LPR Probe, Dual pH (Esophageal), LPR Acid, Locator Port 6cm
• 00816734022221: LPR Probe, Dual pH (Esophageal), LPR Acid, Locator Port 6cm
• 00816734022214: Single-Use Z/pH Probe (External Reference), Dual pH (Gastric and Esophageal), Locator Port 6cm
• 00816734022207: Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal), Locator Po
• 00816734022191: Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Esophageal) with LES Locator, Locat
• 00816734022115: Bioview® Manometry Acquisition Software
• 00816734022108: Single-Use pH Probe, Non-Infused, Single pH (Esophageal)
• 00816734022092: Single-Use pH Probe, Non-Infused, Single pH (Esophageal)
• 00816734022085: Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) with LES Port
• 00816734022078: Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 21cm Spacing
• 00816734022061: Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 15cm Spacing
• 00816734022054: Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 10cm Spacing
• 00816734022047: Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 10cm Spacing
• 00816734022030: Single-Use pH Probe, Infused, Single pH (Esophageal) with LES Port
• 00816734022023: Single-Use pH Probe, Infused, Dual pH (Esophageal) 5cm Spacing with LES Port
• 00816734022016: Single-Use pH Probe, Infused, Dual pH (Esophageal) 15cm Spacing with LES Port
• 00816734022009: Single-Use pH Probe, Infused, Dual pH (Esophageal) 10cm Spacing with LES Port
• 00816734021934: EFT Viscous Solution
• 00816734021927: Buffer Solution, pH 7.0 +/- 0.05 @ 25C, 250ml
• 00816734021910: Buffer Solution, pH 4.0 +/- 0.05 @ 25C, 250ml
• 00816734021903: Buffer Solution, pH 1.0 +/- 0.05 @ 25C, 250ml
• 00816734021897: Buffer Solution, pH 7.0 +/- 0.05 @ 25C, 500ml
• 00816734021880: Buffer Solution, pH 4.0 +/- 0.05 @ 25C, 500ml