FDA.report

JosNoe Medical Inc

Primary DI
00850003294285
Brand
JosNoe Medical Inc
Company
JOSNOE MEDICAL, INC.
Model
JNM-200016
Device description
Dual Chamber Scope Warmer that Pre-Warms Multiple Laparoscopes.
Published
2019-11-05
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
NWVLaparoscopic Accessories, Gynecologic

Product Code Classifications

CodeDeviceSpecialtyClass
NWVLaparoscopic Accessories, GynecologicObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850003294285PackageGS110In Commercial Distribution
00850003294278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003294285008500032942858500032942850850003294285
00850003294278008500032942788500032942780850003294278

GMDN Terms

TermDefinition
Instrument warmer, exothermic chemicalA sterile heating device intended to warm patient-contact instruments (e.g., rigid endoscopes or trocars) before they are introduced into body orifices or other parts of the body. It typically consists of an envelope that is wrapped around the instrument (e.g., laparoscope), and filled with a material which produces an exothermic chemical reaction when activated. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature28 Degrees Fahrenheit0 Degrees Fahrenheit

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
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
00850003294353JosNoe Medical IncSP-1042019-10-31
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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