EsoFLIP

Primary DI
05391530810036
Brand
EsoFLIP
Company
Covidien LP
Model
ES-320
Device description
EsoFLIP Dilation Catheter for use with EndoFLIP System
Published
2016-08-02
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
PIEEsophageal Dilator With Balloon And Electrode Sensors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PIEEsophageal Dilator With Balloon And Electrode SensorsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142000000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142000000ESOFLIP ESCrospon, Ltd.2014-09-25PIE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391530810081PackageGS15In Commercial Distribution
05391530810036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391530810081053915308100815391530810081
05391530810036053915308100365391530810036

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal/biliary dilation balloon catheterA long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, and may be of the fixed-wire or wire-guided type. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter20Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8552767766info@crospon.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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10884521713208EdgeE1455B2016-11-18
10884521713277EdgeE1475X2016-11-18
20884521103631Mallinckrodt5-182372015-08-28
20884521105574Mallinckrodt5-185412015-08-28
40884521105578Shiley5-185412018-05-16
10884521543881SigniaSIGMRET2017-07-24
10884521543874SigniaSIGRIG2017-07-31
10884521620254Shiley862342016-09-24
10884521543812SigniaSIGADAPTXL2017-08-08
10884521101098NellcorMAXPACAI2016-09-24
10884521543782SigniaSIGPHANDLE2017-08-08
10884521543867SigniaSIGSBCHGR2017-08-01
10884521128927SonicisionSCST2016-09-24
10884521543829SigniaSIGADAPTSHORT2017-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521809437EsoFLIPCovidien LPPIE2021-03-15
10884521809444EsoFLIPCovidien LPPIE2021-03-15
20884521809434EsoFLIPCovidien LPPIE2021-03-15
20884521809441EsoFLIPCovidien LPPIE2021-03-15
05391530810135EsoFLIP Covidien LPPIE2020-04-16
05391530810159EsoFLIP CROSPON LIMITEDPIE2020-04-16
05391530810043EsoFLIPCovidien LPPIE2016-08-02