AccessGUDID - DEVICE: CarboTrack (00860004308409)

GUDID

Device Identifier (DI) Information

Brand Name: CarboTrack
Version or Model: CT-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: JADA MEDICAL LLC

Primary DI Number: 00860004308409
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045239559 *Terms of Use

Device Description: Carbon Dioxide Airway Adapter

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?
62698	Capnography sampling adaptor	A non-sterile device intended to enhance the capture of exhaled end-tidal carbon dioxide (EtCO2) for evaluation of a patient's ventilatory, circulatory, or metabolic status, typically during the administration of anaesthesia. It is an adhesive, dome-like adaptor with connecting ports designed to function as an interface between an in situ airway device (e.g., oropharyngeal airway, face mask, nasal oxygen cannula) and respiratory sampling tubing connected to a carbon dioxide monitor (capnograph). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PHS	Oral Airway Assist

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 -30 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7b7844f3-2750-4145-b43d-e1de22d26eb8
Public Version Date: March 01, 2021
Public Version Number: 1
DI Record Publish Date: February 19, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10860004308406	10	00860004308409		In Commercial Distribution	10 EA dispenser box
20860004308403	10	10860004308406		In Commercial Distribution	Case

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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 2403892292
Email: customercare@jadamedical.com

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