DEVICE: N/A (05030267140329)

Device Identifier (DI) Information

N/A
2026036
In Commercial Distribution

INTERSURGICAL INCORPORATED
05030267140329
GS1

1
785952607 *Terms of Use
22MM SINGLE HEATED WIRE BREATHING SYSTEM WITH AUTO FILL CHAMBER
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Ventilator breathing circuit, single-use A non-sterile assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K092129 000
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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

5dd10371-be86-4b0e-ae5d-574c95af518c
July 06, 2018
3
September 24, 2016
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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
05030267140336 7 05030267140329 In Commercial Distribution
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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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
3154512900
support@intersurgicalinc.com
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