Model: PFT KIT B - 184114
Catalog: 184114
DI: 00817081028621
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Description
Pulmonary Function Test Kit B, 36 MM O.D.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c2162e9b-027b-4448-9321-cb39c6750c7e
Distribution Status:
In Commercial Distribution
DUNS Number:
020275145
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
00817081028638
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
100
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00817081028621
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00817081028621
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 60506
Name: Pulmonary function testing kit
Definition:
A collection of non-sterile devices intended to be used in conjunction with pulmonary function analysis equipment to perform a pulmonary function test. It may include a breathing mouthpiece, filter (intended to reduce contamination of parent device), and a nose clip. This is a single-use device.
FDA Product Codes
CAH
Filter, Bacterial, Breathing-Circuit
Premarket Submissions
Submission Number:
K000654
Supplement Number:
000