PEP

GUDID 00744229100423

Monitor Set, PEP, w/Hose, DHD

PARI RESPIRATORY EQUIPMENT, INC.

Airway pressure monitor, non-powered

• Primary Device ID: 00744229100423
• NIH Device Record Key: a86206ca-c591-4d08-97fe-5e61998fe217
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEP
• Version Model Number: 044B4612
• Company DUNS: 804736098
• Company Name: PARI RESPIRATORY EQUIPMENT, INC.
• Device Count: 1
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00744229100423 [Package]; Contains: 00744229440383; Package: carton [12 Units]; In Commercial Distribution
GS1	00744229440383 [Primary]

FDA Product Code

• BWF: Spirometer, Therapeutic (Incentive)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-30

Devices Manufactured by PARI RESPIRATORY EQUIPMENT, INC.

• 00744229440796 - Adult Aerosol Mask: 2025-03-31 Adult Aerosol Mask
• 00744229100850 - Vortex: 2024-05-08 Mask, VORTEX, Pediatric Small
• 00744229100867 - Vortex: 2024-05-08 Mask, VORTEX, Pediatric Medium
• 00744229510529 - Vortex: 2024-05-06 Vortex Nonelectrostatic Holding Chmbr
• 00744229510536 - Vortex: 2024-05-01 Vortex w Pediatric Mask Small
• 00744229510543 - Vortex: 2024-05-01 Vortex w Pediatric Mask Medium
• 00744229510512 - Vortex: 2024-05-01 Vortex Hospital Package
• 00744229510598 - Vortex: 2024-05-01 Vortex w Adult Mask