AccessGUDID - DEVICE: Aerotech I Radioaerosol Administration System (00718175087633)

GUDID

Device Identifier (DI) Information

Brand Name: Aerotech I Radioaerosol Administration System
Version or Model: 177-095
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 177-095
Company Name: BIODEX MEDICAL SYSTEMS, INC.

Primary DI Number: 00718175087633
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 043833813 *Terms of Use

Device Description: AeroTech I Shield

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:	Yes
Prescription Use (Rx):	No
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?
16784	Radioaerosol administration set	A collection of devices used to quickly deliver radioaerosol to a patient for ventilatory pulmonary scintigraphy. It is used with an aerosol pump/nebulizer or a compressed air line to generate the radioactive aerosol, and a lead (Pb) protective container to hold the radioactive solution during the inhalation procedure. It typically consists of one or several one-way valves to direct the flow of aerosol to the patient, transport tubing to carry the aerosol to the patient, a mouthpiece, and a bacteria filter to trap any exhaled aerosol. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAF	Nebulizer (Direct Patient Interface)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K800023	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: 1ce34115-c4f5-4f30-9d52-849ca3e577a5
Public Version Date: October 23, 2020
Public Version Number: 1
DI Record Publish Date: October 15, 2020