FDA.reportPublic FDA data

Insufflation Tubing, Universal

Primary DI
10817183020315
Brand
Insufflation Tubing, Universal
Company
NORTHGATE TECHNOLOGIES INC.
Model
7-510-16
Device description
Insufflation tubing for use with Laparoscopic Insufflators
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HIFInsufflator, Laparoscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIFInsufflator, LaparoscopicObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914401000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914401000UNIVERSAL GENERAL USE KIT #7-510-16Northgate Technologies, Inc.1991-11-27HIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817183020315PackageGS110In Commercial Distribution
00817183020318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081718302031510817183020315
00817183020318008171830203188171830203180817183020318

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
627969264
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817183020844Dual CO2 Cylinder Hose7-650-502025-03-31
10817183020841Dual CO2 Cylinder Hose7-650-502025-03-31
00817183020820StimSite AM-VY1 AdapterAM-VY12024-07-10
00817183020813PUREPNEUMO Tubing Set7-650-012024-07-09
10817183020810PUREPNEUMO Tubing Set7-650-012024-07-09
00817183020769StimSite Signal BoxAM-1012024-04-29
00817183020417Suction Tubing Set7-510-442019-02-22
00817183020622Suction Tubing Set72-00327-02019-06-19
00817183020776StimSite Activation CardAM-21012023-11-21
00817183020660NEBULAE SRS Tubing Set7-510-572023-02-14
00817183020684NEBULAE SRS Laparoscopic Surgical Pump7-700-002023-02-14
00817183020714N/A7220399572-00273-02021-01-05
00817183020721N/A720597272-00166-02021-01-05
00817183020738N/A427072-00146-02021-01-05
00817183020196CO2 Hose and Yoke7-510-092016-10-13
00817183020202CO2 Hose and Yoke Shuttle Valve System7-510-502016-10-13
00817183020257CO2 Hose and DISS7-510-342016-10-14
00817183020264CO2 Hose and DIN7-510-362016-10-14
00817183020226Insufflation Tubing, Laparoscopic7-510-522016-10-13
00817183020301Insufflation Tubing, Gen Use 15mm7-510-152016-10-14

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