FDA.reportPublic FDA data

NOVII INTERFACE CABLE

Primary DI
05060433670114
Brand
NOVII INTERFACE CABLE
Company
Datex-Ohmeda, Inc.
Model
GE MECG
Catalog number
105-PT-104
Device description
NOVII INTERFACE CABLE - GE MECG
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
05060433670114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060433670114050604336701145060433670114

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 Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
118933716
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682143684IV POLE ASSY 12 IN12 Inch IV10217-5378-8002022-12-06
00195278115171NOVIINOVII+ POD2024-06-03
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
05060433670091NOVII INTERFACE CABLEGE FECG105-PT-1022016-09-12
05060433670138NOVII INTERFACE CABLEGE UA105-PT-1062016-09-12
00195278212313NOVIINOVII+ INTERFACE2024-06-03
00840682143677Giraffe In-Bed ScaleGS12022-12-08
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
05060433670091NOVII 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