DEVICE: N/A (00619498213160)

Device Identifier (DI) Information

N/A
RM21316
In Commercial Distribution

Intersurgical Incorporated
00619498213160
GS1

1
785952607 *Terms of Use
15MM S/BORE SINGLE PATIENT CIRCUIT W/EXH VALVE 1.6M, ELISE
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
Yes
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?
37706 Ventilator breathing circuit, single-use
An 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 artificial airway/respiratory mask (not included). 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 a carbon dioxide cuvette and/or 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.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
CBP Valve, Non-Rebreathing
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K132143 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Lumen/Inner Diameter: 15 Millimeter
Length: 160 Centimeter
CLOSE

Device Record Status

d81b4eef-a831-4000-ab01-d9bc628657c1
February 11, 2025
7
September 17, 2015
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05030267116218 15 00619498213160 In Commercial Distribution
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
3154512900
support@intersurgicalinc.com
CLOSE