DEVICE: RejuvaHeart (00868331000409)

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Device Record History
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Device Identifier (DI) Information
RejuvaHeart
NCP-2
In Commercial Distribution
No
NORTH AMERICAN ECP INC.
00868331000409
GS1

1
080070558 *Terms of Use
External Counter Pulsation Device
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
61282 External counterpulsation system, stationary
A noninvasive, stationary assembly of devices intended to assist the blood circulation of an adult patient suffering from heart disease through the electrocardiogram (ECG) synchronized inflation of pressure cuffs worn around the extremities/buttocks. It includes a patient bed with inflatable cuffs, an air pump, ECG cables, and either a control unit or software for use with a personal computer (PC); it may include a pulse oximeter probe. The cuffs are intended to inflate from the most distal to the most proximal during diastole and deflate during systole to increase preload/decrease afterload. The system is intended to be operated by a professional in a clinical setting.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DRN Device, Counter-Pulsating, External
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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

[?]
Storage and Handling
Handling Environment Humidity: between 35 and 65 Percent (%) Relative Humidity
Handling Environment Temperature: between 18 and 24 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Height: 29 Inch
Length: 80 Inch
Width: 35.25 Inch
Width: 30 Inch
Height: 66.5 Inch
Length: 18.5 Inch
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Device Record Status
527acb10-733c-454e-88af-3df5a17871b7
March 29, 2018
2
October 17, 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)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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