Pulmoguard 29-3201-050

GUDID B279S293201200

Bacterial Pulmonary Function Filter

S D I DIAGNOSTICS INC

Pulmonary function testing filter/mouthpiece

• Primary Device ID: B279S293201200
• NIH Device Record Key: 048abdb3-8c34-4fc9-b2b8-89bf28c5c079
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pulmoguard
• Version Model Number: A
• Catalog Number: 29-3201-050
• Company DUNS: 037690120
• Company Name: S D I DIAGNOSTICS INC
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B279S293201050 [Primary]
HIBCC	B279S29320105001 [Unit of Use]
HIBCC	B279S293201200 [Package]; Contains: B279S293201050; Package: [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934509

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-21
• Device Publish Date: 2024-03-13

On-Brand Devices [Pulmoguard]

• B279S298997100: Pulmonary Function Test Filter
• B279S298997050: Pulmonary Function Test Filter
• B279S298993300: II
• B279S298993100: II
• B279S298993200: II
• B279S297958080: Pulmonary Function Test Filter
• B279S297958040: Pulmonary Function Test Filter
• B279S297957080: Pulmonary Function Test Filter
• B279S297957040: Pulmonary Function Test Filter
• B279S297954100: Pulmonary Function Test Filter
• B279S297954050: Pulmonary Function Test Filter
• B279S297953080: Pulmonary Function Test Filter
• B279S297953040: Pulmonary Function Test Filter
• B279S297951100: Pulmonary Function Test Filter
• B279S297951050: Pulmonary Function Test Filter
• B279S297950300: I
• B279S297950200: I
• B279S297950100: I
• B279S297950050: I
• B279S297948080: Pulmonary Function Test Filter
• B279S297948040: Pulmonary Function Test Filter
• B279S297947100: Pulmonary Function Test Filter
• B279S297947050: Pulmonary Function Test Filter
• B279S297946080: Pulmonary Function Test Filter
• B279S297946040: Pulmonary Function Test Filter
• B279S297944080: Pulmonary Function Test Filter
• B279S297944040: Pulmonary Function Test Filter
• B279S297943080: Pulmonary Function Test Filter
• B279S297943040: Pulmonary Function Test Filter
• B279S297942100: Pulmonary Function Test Filter
• B279S297942050: Pulmonary Function Test Filter
• B279S297941080: Pulmonary Function Test Filter
• B279S297941040: Pulmonary Function Test Filter
• B279S297933080: Pulmonary Function Test Filter
• B279S297933040: Pulmonary Function Test Filter
• B279S297932080: Pulmonary Function Test Filter
• B279S297932040: Pulmonary Function Test Filter
• B279S297931100: Pulmonary Function Test Filter
• B279S297931050: Pulmonary Function Test Filter
• B279S297930300: II
• B279S297930100: II
• B279S297930200: II
• B279S297928080: Pulmonary Function Test Filter
• B279S297928040: Pulmonary Function Test Filter
• B279S297927080: Pulmonary Function Test Filter
• B279S297927040: Pulmonary Function Test Filter
• B279S297925080: Pulmonary Function Test Filter
• B279S297925040: Pulmonary Function Test Filter
• B279S297924100: Pulmonary Function Test Filter
• B279S297924050: Pulmonary Function Test Filter