AccessGUDID - DEVICE: Breathing Circuit (00848530093204)

GUDID

Device Identifier (DI) Information

Brand Name: Breathing Circuit
Version or Model: VC1114
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530093204
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 141668116 *Terms of Use

Device Description: Adult Single Limb Passive Heated Wire Circuit - Fisher & Paykel

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?
60966	Respiratory gas heating wire, adult	A non-sterile device intended to be integrated within a ventilator breathing circuit and used in conjunction with a heated respiratory humidifier (from which it draws its power) to maintain the temperature of inspiratory gasses during ventilation of an adult patient. It typically consists of a compact heating unit and a length of heated wire which is integrated within the lumen of an adult breathing circuit tube. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)

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: c91f32a7-7c50-424c-a9c1-612cd5ea5915
Public Version Date: June 17, 2024
Public Version Number: 1
DI Record Publish Date: June 07, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found 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: 877-578-6738
Email: customerservice@sunsethcs.com

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