DEVICE: Pall® Pro-Tec Filter for Pulmonary Function Testing (05034480309143)

Download: XML | JSON

Device Identifier (DI) Information

Pall® Pro-Tec Filter for Pulmonary Function Testing
PF30S
PF30S
Pall International Sàrl
05034480309143
GS1
1
Pulmonary Function Filter for pulmonary function testing
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
BZG SPIROMETER, DIAGNOSTIC
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 99.9999% crosscontamination reduction efficiency (when used according to the instructions for use)
CLOSE

Device Status

In Commercial Distribution
July 20, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
35034480309144 25 05034480309143 In Commercial Distribution case
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)645-6578 5164843600
QAMedical@pall.com
CLOSE