FDA.reportPublic FDA data

PUREPNEUMO Tubing Set

Primary DI
10817183020810
Brand
PUREPNEUMO Tubing Set
Company
NORTHGATE TECHNOLOGIES INC.
Model
7-650-01
Device description
Paired Insufflation and TAP Tubing
Published
2024-07-09
Public version status
New
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
NKCTubing/Tubing With Filter, Insufflation, Laparoscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKCTubing/Tubing With Filter, Insufflation, LaparoscopicObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817183020810PackageGS110In Commercial Distribution
00817183020813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081718302081010817183020810
00817183020813008171830208138171830208130817183020813

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
627969264
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
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
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
00817183020318Insufflation Tubing, Universal7-510-162016-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493412498RIVA Posterior Fixation SystemXENIX MEDICAL LLCNKC2026-02-16
00840493412535RIVA Posterior Fixation SystemXENIX MEDICAL LLCNKC2026-02-16
15060120950571Insufflation FilterGVS FILTER TECHNOLOGY UK LTDNKC2025-12-11
16931918171258AllesetGRI Medical & Electronic Technology Co., Ltd.NKC2025-12-09
26931918171255AllesetGRI Medical & Electronic Technology Co., Ltd.NKC2025-12-09
30326053102791Regard™Resource Optimization & Innovation, L.L.C.NKC2025-11-21
04711605992053The O R Company - InsufflatOR Tubing SetADVANCED MEDICAL DESIGN CO., LTD.NKC2025-07-28
04048551067444NAKarl Storz GmbH & Co. KGNKC2025-03-28
04048551326664NAKarl Storz GmbH & Co. KGNKC2025-03-28
00817183020813PUREPNEUMO Tubing SetNORTHGATE TECHNOLOGIES INC.NKC2024-07-09
04055207070093NARichard Wolf GmbHNKC2024-05-24
04055207070109NARichard Wolf GmbHNKC2024-05-24
04897106955862andorate® CO2 Source Tubing AdapterGA Health Company LimitedNKC2023-08-30
14897106955869andorate® CO2 Source Tubing AdapterGA Health Company LimitedNKC2023-08-30
04897106955855andorate® CO2 Source Tubing AdapterGA Health Company LimitedNKC2023-08-28
14897106955852andorate® CO2 Source Tubing AdapterGA Health Company LimitedNKC2023-08-28
00628725007366SterisCanadian Hospital Specialties LimitedNKC2023-08-23
00628725007373SterisCanadian Hospital Specialties LimitedNKC2023-08-23
00628725007380SterisCanadian Hospital Specialties LimitedNKC2023-08-23
00628725007397SterisCanadian Hospital Specialties LimitedNKC2023-08-23
50628725007361CHSCanadian Hospital Specialties LimitedNKC2023-08-23
50628725007378CHSCanadian Hospital Specialties LimitedNKC2023-08-23
50628725007385CHSCanadian Hospital Specialties LimitedNKC2023-08-23
50628725007392CHSCanadian Hospital Specialties LimitedNKC2023-08-23
30326053102784Regard™Resource Optimization & Innovation, L.L.C.NKC2023-07-28
30326053102807Regard™Resource Optimization & Innovation, L.L.C.NKC2023-07-28
30326053102814Regard™Resource Optimization & Innovation, L.L.C.NKC2023-07-28
20326053102787Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.NKC2023-07-28
20326053102800Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.NKC2023-07-28
20326053102817Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.NKC2023-07-28