7500 V MASK 669154

GUDID 00874750000685

PETITE FACE MASK 7500

HANS RUDOLPH, INC.

CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable

• Primary Device ID: 00874750000685
• NIH Device Record Key: 0ffbe7b4-6c61-4862-b646-700b4a5139e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 7500 V MASK
• Version Model Number: 7500
• Catalog Number: 669154
• Company DUNS: 007131725
• Company Name: HANS RUDOLPH, INC.
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00874750000685 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030515

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

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: 2023-04-13
• Device Publish Date: 2023-04-05

On-Brand Devices [7500 V MASK]

• 00874750000180: 7500 EX SM 22ID ELB Q-REL HDGR
• 00874750000173: 7500 SMALL 22ID ELB Q-REL HDGR
• 00874750000166: 7500 MED 22ID ELBOW Q-REL HDGR
• 00874750000098: 7500 PETITE 22ID ELB STD HDGR
• 00874750000029: 7500 SMALL 22OD ELB W/STD HDGR
• 00874750000012: 7500 MED 22OD ELBOW W/STD HDGR
• 00874750000005: 7500 LARGE 22OD ELB W/STD HDGR
• 00874750004003: SWVLPORT STR 75 22ID PC GREEN
• 00874750003990: SWVLPORT STR 75 22OD PC GREEN
• 00874750003983: SWVLPORT ELB 7500 22ID PC GRN
• 00874750003976: SWVLPORT ELB 75 22OD PC GRN
• 00874750000685: PETITE FACE MASK 7500
• 00874750000678: EXTRA SMALL FACE MASK 7500
• 00874750000661: SMALL FACE MASK 7500
• 00874750000654: MEDIUM FACE MASK 7500
• 00874750000647: LARGE FACE MASK 7500
• 00874750000630: 7500 22ID STRAIGHT SWVL PS NAT
• 00874750000623: 7500 22ID ELBOW SWVL PS NAT
• 00874750000616: 7500 22OD STRAIGHT SWVL PS NAT
• 00874750000609: 7500 22OD ELBOW SWVL PS NAT