AccessGUDID - DEVICE: Microstream Advance (20884521771762)

GUDID

Device Identifier (DI) Information

Brand Name: Microstream Advance
Version or Model: ZMVAI
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Covidien LP

Primary DI Number: 20884521771762
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: Adult-Pediatric Intubated CO2 Filter Line;Short-term use: Procedural/Emergency

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
36306	Nasal oxygen cannula, carbon-dioxide-sampling	A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCK	ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181467	000

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between -4 and 158 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Length: 2 Meter

Device Record Status

Public Device Record Key: 246182c8-31b5-407c-a1cf-4a9db82e6f90
Public Version Date: June 13, 2025
Public Version Number: 3
DI Record Publish Date: January 14, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10884521771765	25	20884521771762		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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(508)261-8000
Email: covidien.udi@covidien.com

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