AccessGUDID - DEVICE: Pulmoguard (B279293104K050)

GUDID

Device Identifier (DI) Information

Brand Name: Pulmoguard
Version or Model: C
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 29-3104K-050
Company Name: S D I DIAGNOSTICS INC

Primary DI Number: B279293104K050
Issuing Agency: HIBCC
Commercial Distribution End Date: March 21, 2022
Device Count: 50
Labeler D-U-N-S® Number*: 037690120 *Terms of Use

Device Description: Pulmonary Function Test Filter

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:	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?
61097	Pulmonary function testing filter/mouthpiece	A non-sterile, portable, screening device intended to be used during pulmonary function testing to remove and retain microdroplets from patient breath to reduce contamination of the parent device; it is also intended to function as a mouthpiece to facilitate access to the patient’s respiratory tract. It is a bidirectional filter, typically in a plastic housing, with a proximal port/mouthpiece; it may have a basic mouthpiece portion capable of being attached to a separate dedicated mouthpiece. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAH	Filter, Bacterial, Breathing-Circuit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K934509	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: 920a2847-d6d8-4fce-90e4-213d6b38b50e
Public Version Date: June 21, 2022
Public Version Number: 4
DI Record Publish Date: July 22, 2016