AccessGUDID - DEVICE: HUDSON RCI (04026704581047)

GUDID

Device Identifier (DI) Information

Brand Name: HUDSON RCI
Version or Model: IPN042803
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1800402
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 04026704581047
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: SOFTFLEX® Tube

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":	No
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?
61346	Straight/elbow breathing circuit connector, single-use	A device intended to create a direct connection between a breathing circuit breathing tube and an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with specific connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It is typically made of plastic materials and can have a straight or elbow-shaped design (excludes Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZO	SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 2b454165-ab6d-4c63-a2a0-ed2167f2ce10
Public Version Date: November 28, 2022
Public Version Number: 6
DI Record Publish Date: September 15, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
24026704581041	1	04026704581047	2019-09-30	Not in Commercial Distribution	Case

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 34026704581048 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(919)544-8000
Email: CS@TELEFLEX.COM

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