FDA.reportPublic FDA data

DEFENDO

Primary DI
00724995231712
Brand
DEFENDO
Company
US Endoscopy
Model
00711904
Catalog number
00711904
Device description
The single-use DEFENDO Olympus EUS Air Water Suction , Biopsy valve - 3-piece kit is used to control the air/water function of an endoscope during a Radial EUS GI procedure.
Published
2024-11-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NWUEndoscope introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWUEndoscope Introducer KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995231719PackageGS125In Commercial Distribution
00724995231712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499523171910724995231719
00724995231712007249952317127249952317120724995231712

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope channel support kitA collection of sterile devices intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes an endoscopic suction valve, an endoscopic air/water valve, and an endoscopic biopsy valve. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
627879687
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995182557Exacto00711094007110942021-03-31
00724995182564Exacto00711095007110952021-03-31
00724995182618Exacto00711115007111152021-03-31
00724995243746Exacto Mundo00711114007111142025-01-31
00724995180959VIA00717001007170012020-01-31
00724995181116VIA00717019007170192020-01-30
00724995181420VIA00717051007170512020-01-30
00724995181451VIA00717054007170542020-01-30
00724995181505VIA00717059007170592020-01-30
00724995181659VIA00717076007170762020-01-30
00724995182984VIA00717141007171412020-01-30
00724995183073VIA00717155007171552020-07-16
00724995183141VIA00717167007171672020-01-30
00724995183257VIA00717182007171822020-01-30
00724995190699VIA00717223007172232020-01-30
00724995190736VIA00717234007172342020-01-30
00724995193966VIA00717269007172692020-02-04
00724995194123VIA00717229007172292020-02-07
00724995194987VIA00717310007173102020-03-23
00724995203412VIA00717337007173372020-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160528358HALYARDAVID MEDICAL, INC.NWU2026-08-01
10198956441842CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956497740CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956501881CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956509511CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956519657CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956537132CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956539174CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956539891CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956346567CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956373945CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956404960CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956439894CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956454224CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956498334CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956498402CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956513037CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956514621CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956518506CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956519428CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956519855CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956520127CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956521179CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956523531CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956530942CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956531338CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956531765CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956532571CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956532649CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956534056CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27