FDA.reportPublic FDA data

NA

Primary DI
10816765013578
Brand
NA
Company
US Endoscopy
Model
00711558
Catalog number
00711558
Device description
The Irrigation Kit CO2 Short includes 1AquaShield System CO2 and Torrent Irrigation Tubing.
Published
2017-04-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

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
10816765013578PackageGS120Not in Commercial Distribution
00816765013571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081676501357810816765013578
00816765013571008167650135718167650135710816765013571

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic insufflation tubing set, single-useA collection of sterile flexible tubing intended to be used as a conduit to deliver a medical gas [e.g., carbon dioxide (CO2), medical air] from its source for insufflation during an endoscopic (including laparoscopic, arthroscopic) procedure. It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include 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
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
627879687
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00724995244545Lumiflex00715506W00715506W2025-06-03
00724995244552Lumiflex00715508W00715508W2025-06-03
00724995244569Lumiflex00715510W00715510W2025-06-03
00724995244576Lumiflex00715512W00715512W2025-06-03
00724995244583Lumiflex00715515W00715515W2025-06-03
00724995244590Lumiflex00715518W00715518W2025-06-03
00724995244606Lumiflex00715506007155062025-06-03
00724995244613Lumiflex00715508007155082025-06-03
00724995244620Lumiflex00715510007155102025-06-03
00724995244637Lumiflex00715512007155122025-06-03
00724995244644Lumiflex00715515007155152025-06-03
00724995244651Lumiflex00715518007155182025-06-03
00724995244668Lumiflex00718006W00718006W2025-06-03

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Primary DI, Brand, Company table
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