Heidelberg pH Capsule System

Primary DI
B989PCCK3300
Brand
Heidelberg pH Capsule System
Company
Heidelberg Medical Inc
Model
Heidelberg pH Capsule Calibration Kit
Catalog number
PCCK330
Device description
The pH Capsule Calibration Kit is designed primarily for activating and calibrating the pH telemetric capsule, it includes the following: the calibration test fixture is a 10-inch square acrylic plate that contains a raised capsule holder for holding the pH capsule during calibration. The acrylic plate also has a clear acrylic block attached to it, for holding 6 test tubes. There are two large round holes in the sides of the plate: for holding the Saline and Rinse contains. There is also provision for placement of the glass Alkaline challenge container. Included with the Kit is a glass container labeled Saline, a glass container labeled Rinse and a glass container labeled NaCH03. The kit contains 6 test tubes, one spool of tether thread, solutions, a 6-inch Delrin capsule holder: for holding the pH capsule during the pH calibration procedure.
Published
2020-11-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFTElectrode, Ph, Stomach

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFTElectrode, Ph, StomachGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B989PCCK3300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal telemetric monitoring systemAn assembly of devices designed to continuously measure and transmit signals for one or more gastrointestinal parameters (i.e., pH, pressure, temperature) or events (e.g., gastrointestinal bleeding) from a patient to a receiving location for viewing. It consists of a battery-powered capsule swallowed by the patient, and a patient-worn or clinician-held unit designed to wirelessly receive data from the capsule to either transmit it (i.e., a transceiver) to a computing device or to display it (e.g., a receiver); various solutions/containers may also be included. It is intended to help diagnose gastric pH disorders and/or measure gastrointestinal transit times to evaluate motility disorders.

Contacts#

Phone, Email table
PhoneEmail
800-241-7517hdlberg@etcmail.com

Regulatory Flags#

DUNS number
023287700
Device count
1
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
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B989HTC1020Heidelberg pH Capsule SystemHeidelberg pH Telemetric CapsulesHTC1022020-11-13
B989EC1150Heidelberg pH Capsule SystemHeidelberg System Equipment CartEC1152020-11-13
B989HCNS180Heidelberg pH Capsule SystemHeidelberg pH Capsule System Software HCNS182020-11-13
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