AccessGUDID - DEVICE: HUDSON RCI (34026704659044)

GUDID

Device Identifier (DI) Information

Brand Name: HUDSON RCI
Version or Model: IPN913699
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1683
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 34026704659044
Issuing Agency: GS1
Commercial Distribution End Date: August 01, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 14026704659040

Device Description: INFANT NASAL CPAP SYSTEM,SIZE 0

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35202	Nasal oxygen cannula, CPAP	A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to deliver oxygen (O2) to the patient and provide continuous positive airway pressure (CPAP) from the devices to which it is connected. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZD	Ventilator, non-continuous (respirator)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K871157	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 067bb073-2731-431d-9fe6-41a0bdba2349
Public Version Date: August 04, 2025
Public Version Number: 4
DI Record Publish Date: October 28, 2022