DEVICE: Suction Cup, ACD-CPR Device (00847946028282)

Device Identifier (DI) Information

Suction Cup, ACD-CPR Device
12-0586-000
In Commercial Distribution

Zoll Medical Corporation
00847946028282
GS1

1
055363428 *Terms of Use
SUCTION CUP, ACD-CPR DEVICE
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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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?
17169 Demand valve
A non-sterile device that is used to regulate the therapeutic gas flow to a patient in response to the patient's breathing effort. It is used, e.g., in ventilator breathing circuits, resuscitation devices and in on demand analgesia devices. This is a reusable device.
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41882 Cardiac resuscitator, manual
A manually-operated external device (a hand-powered pump) designed to be applied to the chest of a patient suffering cardiac arrest so that a healthcare professional or layperson can administer rhythmic compression to the chest in the region of the heart to provide blood flow during cardiopulmonary resuscitation (CPR). It typically consists of central piston, a soft but firm base, (a ring) that contacts the chest, a strong spiralled spring that transfers the users applied force to the piston, and a large handle for the user's hands. The compression force can be adjusted to a pre-set load to achieve equal delivered compressions to prevent damage to the ribs/organs. This is a reusable device.
Active false
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FDA Product Code

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Product Code Product Code Name
PIZ Combination compression/decompression manual chest pump with impedance respiratory valve
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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

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Storage and Handling
Handling Environment Temperature: exactly 0 Degrees Celsius
Storage Environment Atmospheric Pressure: more than 0 KiloPascal
Storage Environment Humidity: exactly 0 Percent (%) Relative Humidity
Storage Environment Temperature: exactly 0 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

d5da9614-ee82-40b9-90fd-3835d3959e07
July 02, 2020
1
June 24, 2020
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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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Yes
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
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Customer Contact

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No Customer Contact currently defined
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