Home GUDID 07290101364825 PillCam
Primary DI 07290101364825
Brand PillCam
Company Given Imaging, Inc.
Model FGS-0521
Device description COLON 2 capsule, 5-pack
Published 2017-02-01
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
Single use true Product Codes# Code, Name table Code Name PGD Colon capsule imaging system
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PGD Colon Capsule Imaging System Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07290101364825 Primary GS1 0 10884521726017 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07290101364825 07290101364825 7290101364825 10884521726017 10884521726017
GMDN Terms# Term, Definition table Term Definition Video capsule endoscopy system An assembly of electronic devices designed for the internal visualization and examination of sections of the gastrointestinal (GI) tract using a non-digestible video capsule after it has been swallowed by a patient. The system typically consists of an operator workstation, various types of video capsules, an external sensor device that receives the wireless signals from the capsule, and a data recorder. As the capsule passes through the GI tract, video images of it sections (e.g., oesophagus, small bowel and colon) are relayed to the operator for examination and data recording; the capsule is egested from the gut.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 20 Degrees Celsius 40 Degrees Celsius Special Storage Condition, Specify 0 0 ; Storage Environment Temperature 0 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 090073722 Device count 5 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07290110360825 PillCam Given Imaging, Inc. PGD 2018-06-22 07290110360818 PillCam Given Imaging, Inc. PGD 2018-06-20 07290101360629 Pillcam Given Imaging, Inc. PGD 2017-03-24 07290101360636 Pillcam Given Imaging, Inc. PGD 2017-03-24 07290101363002 Pillcam Given Imaging, Inc. PGD 2017-02-02 07290101363040 Pillcam Given Imaging, Inc. PGD 2017-02-02 07290101364795 PillCam Given Imaging, Inc. PGD 2017-02-01 07290101364801 PillCam Given Imaging, Inc. PGD 2017-02-01 07290101364788 PillCam Given Imaging, Inc. PGD 2017-01-31 07290101364818 PillCam Given Imaging, Inc. PGD 2017-01-31 07290101364832 PillCam Given Imaging, Inc. PGD 2017-01-31 07290101362128 RAPID Given Imaging, Inc. PGD 2016-09-24
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