AccessGUDID - DEVICE: nSpire Health (00852417003255)

GUDID

Device Identifier (DI) Information

Brand Name: nSpire Health
Version or Model: Wright Respirometer Mk 8
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 700-008
Company Name: NSPIRE HEALTH LTD

Primary DI Number: 00852417003255
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 216706895 *Terms of Use

Device Description: Wright Respirometer Mk 8

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?
61544	Monitoring spirometer, mechanical	A portable mechanical device designed to continuously measure tidal and/or minute volume of a spontaneously-breathing or mechanically-ventilated patient, for the evaluation of the patient’s ventilatory status during intensive care treatment, anaesthesia, and postoperative recovery; it may also be used to measure tidal/minute volume and respiration rate delivered to a patient via the expiratory ports of resuscitation devices to evaluate their performance. It consists of an airflow-driven turbine/dial which indicates the air volume passed.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZK	Spirometer, Monitoring (W/Wo Alarm)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091853	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0fdd2f5f-1ce2-4f42-8686-91f66a436d18
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 24, 2017