FDA.reportPublic FDA data

JosNoe Medical Inc

Primary DI
00850003294117
Brand
JosNoe Medical Inc
Company
JOSNOE MEDICAL, INC.
Model
PS-500
Device description
Scope warmer that pre-warms multiple laparoscopes.
Published
2019-07-16
Public version status
Update
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
IMDPack, Hot Or Cold, Disposable
NWVLaparoscopic Accessories, Gynecologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMDPack, Hot Or Cold, DisposablePhysical Medicine1
NWVLaparoscopic Accessories, GynecologicObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850003294032PackageGS110In Commercial Distribution
00850003294117PackageGS130In Commercial Distribution
00850003294001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003294032008500032940328500032940320850003294032
00850003294117008500032941178500032941170850003294117
00850003294001008500032940018500032940010850003294001

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature28 Degrees Fahrenheit0 Degrees Fahrenheit

Sterilization Methods#

Method table
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 DI, Brand, Model table
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
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

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