FDA.reportPublic FDA data

JosNoe Medical Inc

Primary DI
00850003294193
Brand
JosNoe Medical Inc
Company
JOSNOE MEDICAL, INC.
Model
TM-6000
Device description
Insufflation Tubing Set with Filter, Funnel Connector and Luer Lock
Published
2019-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00850003294230PackageGS110In Commercial Distribution
00850003294193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003294230008500032942308500032942300850003294230
00850003294193008500032941938500032941930850003294193

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.

Regulatory Flags#

DUNS number
965627859
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850003294841GynexGYN SE82002024-11-08
00850003294834GynexGYN SE82002024-11-08
00850003294070JosNoe Medical IncPFITF-102019-09-11
00850003294346JosNoe Medical IncSP-1042019-10-31
00850003294407JosNoe Medical IncJNM-OC84S2019-11-05
00850003294445JosNoe Medical IncJNM-OC84S-RTP2019-11-05
00850003294476JosNoe Medical IncHS-1002019-11-05
00850003294513JosNoe Medical IncHF-7001S2019-11-05
00850003294506JosNoe Medical IncHS-100-NSM-502019-11-05
00850003294254JosNoe Medical IncJNM-1222-NSM-502019-10-31
00850003294261JosNoe Medical IncTM-6000-NSM-502019-10-31
00850003294308JosNoe Medical IncSP-1022019-10-31
00850003294339JosNoe Medical IncSP-102-NSM-502019-10-31
00850003294155JosNoe Medical IncJNM-12222019-10-28
00850003294223JosNoe Medical IncITF10-NSM-502019-10-02
00850003294377JosNoe Medical IncJNM-02032019-11-05
00850003294278JosNoe Medical IncJNM-2000162019-11-05
00850003294285JosNoe Medical IncJNM-2000162019-11-05
00850003294384JosNoe Medical IncJNM-02032019-11-05
00850003294421JosNoe Medical IncJNM-OC84S2019-11-05

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
10817183020810PUREPNEUMO 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