FDA.report

NA

Primary DI
00884838014602
Brand
NA
Company
INVIVO CORPORATION
Model
452230032811
Catalog number
452230032811
Published
2017-03-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MWIMONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Product Code Classifications

CodeDeviceSpecialtyClass
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00884838014602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838014602008848380146028848380146020884838014602

GMDN Terms

TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(999)999-9999xx@xx.xx

Regulatory Flags

DUNS number
013649151
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
false
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 DIBrandModelCatalogPublished
00884838103740Sentinelle4598018134412023-02-24
00884838115279Invivo9896-032-072922022-11-22
00884838115309Invivo9896-032-079732022-11-22
00884838115255Invivo9896-031-107352022-11-20
00884838115507Sentinelle9896-032-165412022-10-14
00884838115514Sentinelle9896-032-165612022-10-14
00884838105195Sentinelle4598-017-162912022-10-12
00884838105201Sentinelle4598-017-163012022-10-12
00884838105218Sentinelle4598-017-163112022-10-12
00884838105225Sentinelle4598-017-163212022-10-12
00884838105232Sentinelle4598-017-163312022-10-12
00884838105331Sentinelle4598-018-575112022-10-12
00884838105300Sentinelle4598-017-430512022-10-11
00884838105249Sentinelle4598-017-163412022-09-26
00884838105256Sentinelle4598-017-163512022-09-26
00884838105263Sentinelle4598-017-163712022-09-26
00884838105270Sentinelle4598-017-163812022-09-26
00884838105287Sentinelle4598-017-163912022-09-26
00884838105294Sentinelle4598-017-216912022-09-26
00884838105317Sentinelle4598-018-040212022-09-26

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