FDA.report

JosNoe Medical Inc

Primary DI
00850003294353
Brand
JosNoe Medical Inc
Company
JOSNOE MEDICAL, INC.
Model
SP-104
Device description
Dual Line Insufflation Set with Filter, Quick Connector, and Luer Lock
Published
2019-10-31
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

Related Records

Product Codes

CodeName
NKCTubing/Tubing With Filter, Insufflation, Laparoscopic

Product Code Classifications

CodeDeviceSpecialtyClass
NKCTubing/Tubing With Filter, Insufflation, LaparoscopicObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850003294353PackageGS110In Commercial Distribution
00850003294346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003294353008500032943538500032943530850003294353
00850003294346008500032943468500032943460850003294346

GMDN Terms

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

Regulatory Flags

DUNS number
965627859
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 DIBrandModelCatalogPublished
00850003294834GynexGYN SE82002024-11-08
00850003294285JosNoe Medical IncJNM-2000162019-11-05
00850003294384JosNoe Medical IncJNM-02032019-11-05
00850003294421JosNoe Medical IncJNM-OC84S2019-11-05
00850003294452JosNoe Medical IncJNM-OC84S-RTP2019-11-05
00850003294483JosNoe Medical IncHS-1002019-11-05
00850003294506JosNoe Medical IncHS-100-NSM-502019-11-05
00850003294520JosNoe Medical IncHF-7001S2019-11-05
00850003294094JosNoe Medical IncJNM-LG012019-11-04
00850003294230JosNoe Medical IncTM-60002019-10-31
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
00850003294124JosNoe Medical IncPFITF-102019-09-11
00850003294117JosNoe Medical IncPS-5002019-07-16

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