AccessGUDID - DEVICE: n/a (00607511801128)

GUDID

Device Identifier (DI) Information

Brand Name: n/a
Version or Model: SO-1990
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SO-1990
Company Name: SALTER LABS

Primary DI Number: 00607511801128
Issuing Agency: GS1
Commercial Distribution End Date: July 24, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 022721133 *Terms of Use

Device Description: Adult Nasal High Performance Sensor Cannula 7 1/4" Connect Tubing P/N: 29-4401 Disposable Single Patient Use Only. Note: incorrect DI, see ABM SO number for 5530-0, reference.

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
35194	Respiratory apnoea monitoring system	An assembly of devices designed to detect the cessation of breathing (apnoea) in infants and adults who are at risk of respiratory failure to alert a parent or attendant of the life-threatening episode(s). It alarms primarily upon the cessation of breathing timed from the last detected breath, and may also include indirect methods of apnoea detection such as monitoring of heart rate and other physiological parameters associated with respiration. It may print-out this data. It will typically include a mains electricity (AC-powered) monitoring unit with software, patient leads, and possibly a recorder to record, display, or print data on a patient's breathing condition.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNR	VENTILATORY EFFORT RECORDER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151874	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
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Storage Environment Temperature: between -40 and 60 Degrees Celsius
Special Storage Condition, Specify: N/A

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Adult

Device Record Status

Public Device Record Key: 908a4ad4-6c71-4f9a-936d-f23bf5417357
Public Version Date: July 27, 2020
Public Version Number: 5
DI Record Publish Date: November 30, 2016