DEVICE: VOCSN Internal Bacterial Filter (00855573007402)

Device Identifier (DI) Information

VOCSN Internal Bacterial Filter
10-Pack
In Commercial Distribution
PRT-00976-000
VENTEC LIFE SYSTEMS, INC.
00855573007402
GS1

10
078758082 *Terms of Use
VOCSN Internal Bacterial Filter, 10-Pack
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Device Characteristics

MR Unsafe
No
Yes
No
No
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?
47083 Portable electric ventilator
A portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through invasive ventilation (i.e., with an artificial airway); it may also be used non-invasively (e.g., with a mask). It includes a control system and alarms, and may include a built-in humidifier. Several methods of cycling and ventilation modes may be used. It may be line and/or internal/external battery-powered for use in the home or a healthcare facility (including ambulatory).
Active false
36998 In-exsufflator
A portable, pneumatic, device that, through a rapid shift in pressure via a face mask, produces a high expiratory flow rate from the lungs, simulating a cough. This technique is referred to as EWNP (exsufflation with negative pressure) or mechanical insufflation-exsufflation. This device is suitable for any patient with an ineffective cough due to, e.g., muscular disorders or paralysis and would typically be used to clear retained broncho-pulmonary secretions, reducing the risk of respiratory complications.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CBK Ventilator, Continuous, Facility Use
NOU Continuous, Ventilator, Home Use
NHJ Device, Positive Pressure Breathing, Intermittent
CAH Filter, Bacterial, Breathing-Circuit
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K162877 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

51bc13b9-499e-4c4a-8577-a64ce34a4470
March 04, 2019
1
January 30, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

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

[?]
Unit of Use DI Number: 00855573007525 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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