DEVICE: HUDSON RCI (04026704558681)

Device Identifier (DI) Information

HUDSON RCI
IPN045509
In Commercial Distribution
880-01KIT
TELEFLEX INCORPORATED
04026704558681
GS1

1
002348191 *Terms of Use
Universal Neonatal ISO-GARD Drain Breathing Circuit Single Heated NIV Limb with Drain
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. 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
OGG Humidifier nebulizer kit
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes 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
No Device Sizes
CLOSE

Device Record Status

62646dc0-dd2b-428a-aed0-0757aa635353
October 24, 2022
4
September 16, 2016
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
24026704558685 20 04026704558681 In Commercial Distribution Case
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)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(919)544-8000
CS@TELEFLEX.COM
CLOSE