AccessGUDID - DEVICE: HUDSON RCI (04026704580316)

GUDID

Device Identifier (DI) Information

Brand Name: HUDSON RCI
Version or Model: IPN042448
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1410
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 04026704580316
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: SMOOTH-FLO® CORR-A-TUBE® II Corrugated Tubing 15 cm (6 in.) Length

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?
32202	Aerosol delivery tubing	A non-sterile length of a flexible, hollow tube, typically large bore (e.g., 22 mm), used in conjunction with an oxygen mask, endotracheal (ET) tube, humidifier, or nebulizer for the delivery of aerosolized humidification, typically oxygen enriched. It is typically supplied in standard coil lengths and is cut by clinical staff to usable lengths. 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: 086822e1-d6e9-4de5-a445-84866f18d643
Public Version Date: December 17, 2019
Public Version Number: 2
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
24026704580310	5	04026704580316	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: 34026704580317 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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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