EDOCS 793980-001

GUDID 00860007698224

EDOCS 120B-22 FINAL ASSEMBLY - 120 LPM AT 85 PSI, 120 LPM AT 2250 PSI, 208-240V/50-60 HZ

Pacific Consolidated Industries LLC

Bulk oxygen concentration system

• Primary Device ID: 00860007698224
• NIH Device Record Key: e6ffcd33-17db-4a3a-a07a-3f2eb1a665e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDOCS
• Version Model Number: EDOCS 120B-22
• Catalog Number: 793980-001
• Company DUNS: 120848411
• Company Name: Pacific Consolidated Industries LLC
• Device Count: 1
• DM Exempt: true
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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	00860007698224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061414

FDA Product Code

• CAW: Generator, Oxygen, Portable

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: 2023-05-16
• Device Publish Date: 2023-05-08

On-Brand Devices [EDOCS]

• 00860007698224: EDOCS 120B-22 FINAL ASSEMBLY - 120 LPM AT 85 PSI, 120 LPM AT 2250 PSI, 208-240V/50-60 HZ
• 00860007698217: EDOCS 120B-21A FINAL ASSEMBLY - 120 LPM AT 85 PSI, 60 LPM AT 2250 PSI, 208-240V/50-60 HZ
• 00860007698200: EDOCS 120B-21 FINAL ASSEMBLY - 120 LPM AT 85 PSI, 60 LPM AT 2250 PSI, 208-240V/50-60 HZ