FDA.reportPublic FDA data

N/A

Primary DI
00817183020714
Brand
N/A
Company
NORTHGATE TECHNOLOGIES INC.
Model
72203995
Catalog number
72-00273-0
Device description
CO2 Shuttle Valve System, Insufflation
Published
2021-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K022052000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K02205200040LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0Northgate Technologies, Inc.2003-01-24HIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885554032338PreviousGS10
00817183020714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885554032338008855540323388855540323380885554032338
00817183020714008171830207148171830207140817183020714

GMDN Terms#

Term, Definition table
TermDefinition
High-pressure medical gas tubingA flexible, cylindrical device that is used to deliver and withstand gases under very high pressure, i.e., greater than 200 bar/3000 pounds per square inch (psi). It may be composed of any of several malleable or semi-rigid materials, e.g., plastic, rubber or nylon, and braided with cotton wool and/or stainless steel. It is typically used to transport high pressure compressed medical gas to a pressure regulating device. It is available in various lengths, including standard coil lengths. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
627969264
Device count
1
Lot or batch
true
Manufacturing date on label
true

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
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
00817183020318Insufflation Tubing, Universal7-510-162016-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973031299207InsufflatorGuangdong Optomedic Technologies, Inc.HIF2026-04-22
04046955813360AESCULAPAesculap AGHIF2025-12-02
B3543000011ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000012ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000013ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000014ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000015ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000019ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000010ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
04046955813353AESCULAPAesculap AGHIF2025-05-18
04953170467219HIGH FLOW INSUFFLATION UNITOLYMPUS MEDICAL SYSTEMS CORP.HIF2025-02-27
04055207007822NARichard Wolf GmbHHIF2024-08-19
04055207008393NARichard Wolf GmbHHIF2024-08-19
04055207058985NARichard Wolf GmbHHIF2024-08-19
05391536920937EVA15PALLIARE LIMITEDHIF2024-07-16
10845854045633AIRSEALConmed CorporationHIF2024-03-27
00886874120699NoneINTUITIVE SURGICAL, INC.HIF2024-03-25
B354OSLPCDG1Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG2Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG3Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG4Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG5Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG51Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG9Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG0Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
00850059707005AccuMedxAccumedx, LLCHIF2024-01-23
00850059707012AccuMedxAccumedx, LLCHIF2024-01-23
10845854045367CONMEDConmed CorporationHIF2023-12-04
09420012433978Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDHIF2023-07-06
10850082007186Filter AssemblyARMM INC.HIF2023-06-08