FDA.reportPublic FDA data

NOVII INTERFACE CABLE

Primary DI
05060433670091
Brand
NOVII INTERFACE CABLE
Company
Datex-Ohmeda, Inc.
Model
GE FECG
Catalog number
105-PT-102
Device description
NOVII INTERFACE CABLE - GE FECG
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OSPUterine Electromyographic Monitor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSPUterine Electromyographic MonitorObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140862000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140862000MONICA NOVII WIRELESS PATCH SYSTEMMonica Healthcare, Ltd.2014-08-27OSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060433670091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060433670091050604336700915060433670091

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118933716
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682143660Panda EU In-Bed ScalePS EU12022-12-08
00840682143714Giraffe EU In-Bed ScaleGS EU12022-12-08
00840682116534BiliSoft Phototherapy SystemBI22016-06-24
00840682116558BiliSoft Phototherapy SystemBI32016-06-24
00840682116565BiliSoft Phototherapy SystemBI12016-06-24
00840682152709Pandai-Res Warmer 1.02020-06-11
00840682103923GiraffeWarmer2016-06-24
00195278358363GIRAFFE PANDA DISPOSABLE SKIN TEMPERATURENA2021-11-10
00840682103909PandaWall Mount Warmer2016-06-24
00840682103916PandaFreestanding Warmer2016-06-24
00840682116855Giraffe Incubator CarestationCS12016-06-24
00840682116862Giraffe OmniBed CarestationCS12016-06-24
00840682142731NoviiPOD 107-PT-0032019-01-29
05060433670114NOVII INTERFACE CABLEGE MECG105-PT-1042016-09-12
05060433670138NOVII INTERFACE CABLEGE UA105-PT-1062016-09-12
00195278115171NOVIINOVII+ POD2024-06-03
00195278212313NOVIINOVII+ INTERFACE2024-06-03
00840682143677Giraffe In-Bed ScaleGS12022-12-08
00840682143684IV POLE ASSY 12 IN12 Inch IV10217-5378-8002022-12-06
00840682143691ROTATING IV POLERotating IV16600-0851-8002022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840682142700NoviiDatex-Ohmeda, Inc.OSP2019-01-29
00840682142731NoviiDatex-Ohmeda, Inc.OSP2019-01-29
07290016406030EmbraceTM Electrodes Array (L)O.B - TOOLS LTDOSP2017-02-12
07290016406016TrueLabor Maternal UnitO.B - TOOLS LTDOSP2016-09-21
07290016406023TrueLabor Monitor AdapterO.B - TOOLS LTDOSP2016-09-21
05060433670053NoviiMONICA HEALTHCARE LIMITEDOSP2016-09-12
05060433670060NoviiMONICA HEALTHCARE LIMITEDOSP2016-09-12
05060433670107MonicaMONICA HEALTHCARE LIMITEDOSP2016-09-12
05060433670244NoviiMONICA HEALTHCARE LIMITEDOSP2016-09-12
05060433670114NOVII INTERFACE CABLEDatex-Ohmeda, Inc.OSP2016-09-12
05060433670138NOVII INTERFACE CABLEDatex-Ohmeda, Inc.OSP2016-09-12
05060433670015NoviiMONICA HEALTHCARE LIMITEDOSP2016-09-12
15060433670050NoviiMONICA HEALTHCARE LIMITEDOSP2016-09-12
35060433670061NoviiMONICA HEALTHCARE LIMITEDOSP2016-09-12
15060433670098MonicaMONICA HEALTHCARE LIMITEDOSP2016-09-12
15060433670104MonicaMONICA HEALTHCARE LIMITEDOSP2016-09-12
15060433670111MonicaMONICA HEALTHCARE LIMITEDOSP2016-09-12
15060433670135MonicaMONICA HEALTHCARE LIMITEDOSP2016-09-12
15060433670241NoviiMONICA HEALTHCARE LIMITEDOSP2016-09-12