Pillcam

Primary DI
07290101363040
Brand
Pillcam
Company
Given Imaging, Inc.
Model
FGS-0448
Device description
sensor belt, C2 Sleeves
Published
2017-02-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PGDColon capsule imaging system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGDColon Capsule Imaging SystemGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123864000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123864000GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEMGiven Imaging , Ltd.2013-08-12NEZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290101363040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290101363040072901013630407290101363040

GMDN Terms#

Term, Definition table
TermDefinition
Video capsule endoscopy systemAn 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
TypeLowHighCondition
Special Storage Condition, Specify00;

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
090073722
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290101365921ManoScanFGS-05712017-07-20
07290101369578ManoViewFGS-06282019-08-11
10884521855441ManoScanFGS-07152025-08-21
07290101364221PillCamRFB-03472017-02-02
04260167480954ManoScan38852016-09-24
04260167480961ManoScan38872016-09-24
04260167482446ManoScan38902016-09-24
04260167482460ManoScan21952016-09-24
04260167482477ManoScan21922016-09-24
04260167482484ManoScan12862016-09-24
07290101365686PillCamRFB-01542016-09-24
10884521853317ManoScanFGS-80382025-01-25
10884521846975PillCam GeniusFGS-08062024-11-29
10884521845848PillCam GeniusFGS-06892024-11-29
20884521845845PillCam GeniusFGS-06892024-11-29
10884521845831PillCam GeniusFGS-06882024-11-14
10884521845916PillCamFGS-08022024-11-14
10884521845923PillCamFGS-08032024-11-14
10884521836181PillCamFGS-07072023-10-05
07290101364474PillcamRFB-03552017-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290110360825PillCamGiven Imaging, Inc.PGD2018-06-22
07290110360818PillCamGiven Imaging, Inc.PGD2018-06-20
07290101360629PillcamGiven Imaging, Inc.PGD2017-03-24
07290101360636PillcamGiven Imaging, Inc.PGD2017-03-24
07290101363002PillcamGiven Imaging, Inc.PGD2017-02-02
07290101364795PillCamGiven Imaging, Inc.PGD2017-02-01
07290101364801PillCamGiven Imaging, Inc.PGD2017-02-01
07290101364825PillCamGiven Imaging, Inc.PGD2017-02-01
07290101364788PillCamGiven Imaging, Inc.PGD2017-01-31
07290101364818PillCamGiven Imaging, Inc.PGD2017-01-31
07290101364832PillCamGiven Imaging, Inc.PGD2017-01-31
07290101362128RAPIDGiven Imaging, Inc.PGD2016-09-24