FDA.reportPublic FDA data

NA

Primary DI
00724995183905
Brand
NA
Company
US Endoscopy
Model
00711555
Catalog number
00711555
Device description
The Irrigation Kit CO2 Short includes 1 AquaShield System CO2 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
10724995183902PackageGS120Not in Commercial Distribution
00816765012963PreviousGS10
00724995183905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499518390210724995183902
00816765012963008167650129638167650129630816765012963
00724995183905007249951839057249951839050724995183905

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
10724995184015Endo-Boot00711621007116212020-04-01
10724995184022Endo-Boot00711622007116222020-04-01
00724995190637ProArmor00711623007116232020-07-16
00724995190644ProArmor00711624007116242020-07-16
00724995180355NA3905133905132020-04-02
00724995180362CO2MPACT7103007103002020-04-02
00724995180386NA7103047103042020-04-02
00724995180409NA7104247104242020-04-02
00724995180416NA7104257104252020-04-02
00724995180423NA7104267104262020-04-02
00724995180430NA7106027106022020-04-02
00724995180447NA7106037106032020-04-02
00724995180454NA7106047106042020-04-02
00724995180522Torrent00711579007115792020-04-01
00724995180768UltramatrixUSBOLUSBOL2020-04-02
00724995180775UltramatrixUSBORUSBOR2020-04-02
00724995180782iSnare00711084007110842020-03-19
00724995180843Articulator00711804007118042020-04-01
00724995182472Short Throw00711018007110182020-03-19
00724995182489Short Throw00711019007110192020-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995180546BioGuardUS EndoscopyPRT2020-04-01
00724995180553BioGuardUS EndoscopyPRT2020-04-01
00724995183899NAUS 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