AccessGUDID - DEVICE: Pro-Tech (00606959006126)

GUDID

Device Identifier (DI) Information

Brand Name: Pro-Tech
Version or Model: STARDUST PTAF
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P1340
Company Name: Respironics, Inc.

Primary DI Number: 00606959006126
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 9999
Device Count: 1
Labeler D-U-N-S® Number*: 080728314 *Terms of Use

Device Description: Pro-Tech Stardust PTAF sensor

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?
35201	Nasal oxygen cannula, basic	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 administer oxygen (O2). It is commonly known as "nasal prongs". This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNR	VENTILATORY EFFORT RECORDER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K982293	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 140 Degrees Fahrenheit
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: efa5b250-6c91-4401-a483-9593ebfc9431
Public Version Date: March 22, 2022
Public Version Number: 4
DI Record Publish Date: September 02, 2016