FDA.report

SJM™

Primary DI
05414734500920
Brand
SJM™
Company
ST. JUDE MEDICAL, INC.
Model
3617
Catalog number
3617
Published
2015-01-19
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

Related Records

Contact Domains

Product Codes

CodeName
NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Product Code Classifications

CodeDeviceSpecialtyClass
NIKDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)Unknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05414734500920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05414734500920054147345009205414734500920

GMDN Terms

TermDefinition
Electrocardiographic electrode, single-useA non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-40 Degrees Celsius70 Degrees Celsius
Handling Environment Temperature-40 Degrees Fahrenheit158 Degrees Fahrenheit
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature-40 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags

DUNS number
790268031
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

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