DEVICE: Current™ (05414734503716)

Device Identifier (DI) Information

Current™
+ VR
In Commercial Distribution
CD1211-36Q
ST. JUDE MEDICAL, INC.
05414734503716
GS1

1
790268031 *Terms of Use
Tiered-therapy cardioverter/defibrillator VVEV VVIR
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Single-chamber implantable defibrillator An implantable pulse generator with a cardiac rhythm recognition system, to analyse an electrocardiogram (ECG), that delivers an electrical impulse(s) to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate. It is implanted in a pouch beneath the skin of the patient's chest or abdomen and has connected leads that are positioned inside or on one heart chamber (typically a ventricle) to monitor the ECG and to automatically deliver the electrical impulse to treat ventricular fibrillation or tachycardia. The device has internal batteries that provide the energy to deliver the discharges; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD).
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FDA Product Code

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Product Code Product Code Name
NVZ Pulse generator, permanent, implantable
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P910023 201
P910023 370
P910023 378
P910023 381
P910023 382
P910023 389
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Handling Environment Temperature: between -20 and 60 Degrees Celsius
Special Storage Condition, Specify: Store the device away from magnets and sources of electromagnetic interference.
Storage Environment Temperature: between 10 and 45 Degrees Celsius
Storage Environment Temperature: between 50 and 113 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
Total Volume: 41 Milliliter
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Device Record Status

d7d0a20c-be57-4dba-a31a-a5b6ce9851ed
July 06, 2018
4
January 24, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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No
Yes
Yes
Yes
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Customer Contact

[?]
+1(855)478-5833
customerservice@sjm.com
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