AccessGUDID - DEVICE: Respironics (00884838044524)

GUDID

Device Identifier (DI) Information

Brand Name: Respironics
Version or Model: 1105136
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1105136
Company Name: Respironics Novametrix, LLC

Primary DI Number: 00884838044524
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 093608594 *Terms of Use

Device Description: CapnoTrak CO2 Sampling Extension Line

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?
66399	Nasal carbon-dioxide-sampling cannula	A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place, to allow sampling of exhaled gas for carbon dioxide (CO2) monitoring; it is not intended to supply oxygen or other medical gases to the patient. It may include attached gas sampling tubing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAT	CANNULA, NASAL, OXYGEN

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
Handling Environment Temperature: between -40 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 261fe1ea-0f9c-4955-9981-11d09cb45fa0
Public Version Date: March 15, 2024
Public Version Number: 5
DI Record Publish Date: September 14, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30884838044525	25	00884838044524		In Commercial Distribution

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: Yes
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(724)744-2500
Email: Respironics.Service@philips.com

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