AccessGUDID - DEVICE: Nellcor (20884521617299)

GUDID

Device Identifier (DI) Information

Brand Name: Nellcor
Version or Model: PMSW-RR-V2.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Covidien LP

Primary DI Number: 20884521617299
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: Respiration Rate Upgrade Kit, PMSW-RR-V2.0, Respiration Rate Version 2.0

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:	No
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?
45554	Patient monitoring system module, respiratory	A small unit dedicated to the measurement and recording of inspired/expired gas flow and airway pressure (Paw). It may also measure, e.g., carbon dioxide (CO2), oxygen (O2), or oesophageal pressure (Pes). It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the parameter/information measured and provided by this module.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQA	Oximeter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141518	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 Humidity: between 15 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 41 and 104 Degrees Fahrenheit
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 57 and 105 KiloPascal
Storage Environment Temperature: between 14 and 158 Degrees Fahrenheit
Handling Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6a4b8e6a-d785-4398-b354-2b565e814e59
Public Version Date: June 13, 2025
Public Version Number: 6
DI Record Publish Date: September 25, 2016

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

Customer Contact

[?]

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

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