FDA.reportPublic FDA data

NA

Primary DI
00724995183899
Brand
NA
Company
US Endoscopy
Model
00711554
Catalog number
00711554
Device description
The Standard Irrigation Kit includes 1 AquaShield System and 1 Torrent Irrigation Tubing.
Published
2020-04-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PRTGastric irrigation and aspiration kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PRTGastric Irrigation And Aspiration KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995183896PackageGS120Not in Commercial Distribution
00816765012956PreviousGS10
00724995183899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499518389610724995183896
00816765012956008167650129568167650129560816765012956
00724995183899007249951838997249951838990724995183899

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic insufflation tubing set, single-useA collection of flexible tubing intended to channel medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

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
00724995180546BioGuardUS EndoscopyPRT2020-04-01
00724995180553BioGuardUS EndoscopyPRT2020-04-01
00724995183905NAUS EndoscopyPRT2020-04-01
00724995183929NAUS EndoscopyPRT2020-04-01
00724995183936NAUS EndoscopyPRT2020-04-01
00724995183943NAUS EndoscopyPRT2020-04-01
10724995180543BioGuardUS EndoscopyPRT2020-04-01
10724995180550BioGuardUS EndoscopyPRT2020-04-01
10724995183896NAUS EndoscopyPRT2020-04-01
10724995183902NAUS EndoscopyPRT2020-04-01
10724995183926NAUS EndoscopyPRT2020-04-01
10724995183933NAUS EndoscopyPRT2020-04-01
10724995183940NAUS EndoscopyPRT2020-04-01