7600 V MASK 201419

GUDID 00874750001361

HEADGEAR SMALL FFM QUICK-REL

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: 00874750001361
• NIH Device Record Key: 621bf4fa-9fd1-482f-9b38-ccaab9df0d19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 7600 V MASK
• Version Model Number: 7600
• Catalog Number: 201419
• 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	00874750001361 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030822

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

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 [7600 V MASK]

• 00874750001125: 7600 SM FF W/AAV 22OD QREL HDG
• 00874750001118: 7600 MD FF W/AAV 22OD QREL HDG
• 00874750001101: 7600 LG FF W/AAV 22OD QREL HDG
• 00874750001132: 7600 ES FF W/AAV 22OD QREL HDG
• 00874750004058: SWVL PORT ASY 7600 22ID PC BLU
• 00874750004027: LARGE V2MASK SI NAT MA/BRACES
• 00874750002986: SWVL PORT ASY 7600 22OD PC BLU
• 00874750002979: AAV SUB 76/77/66/67 POLYC NAT
• 00874750002917: PETIT V2MASK SI NAT MA/BRACES
• 00874750002900: EXSM V2MASK SI NAT MA/BRACES
• 00874750002894: SMALL V2MASK SI NAT MA/BRACES
• 00874750002887: MED V2 MASK SI NAT MA/BRACES
• 00874750002573: MASK SIZING CALIPER 76/75/7800
• 00874750001446: EXTRA SMALL F MASK 7600
• 00874750001439: SMALL FACE MASK 7600
• 00874750001415: LARGE FACE MASK 7600
• 00874750001408: CAP PLUG PKG 2 HRI SAMPLE PORT
• 00874750001385: SWIVEL PORT ASSY W/AAV 22MM ID
• 00874750001378: DIAPH/AAV PORT SUB ASSY 7600
• 00874750001361: HEADGEAR SMALL FFM QUICK-REL
• 00874750001354: HEADGEAR LARGE FFM QUICK-REL
• 00874750001347: SWIVEL PORT ASSY W/AAV 22MM OD
• 00817136027302: SWIVEL PORT QREL 22ID BLUE PC
• 00817136027272: SWIVEL PORT V2QREL 22OD PCBLUE
• 00817136027227: EASY-RELEA BODY/LATCH SET OF 1
• 00817136027197: LOWER STRAP CLIP V2 MASK BRACE
• 00817136027180: UPPER STRAP CLIP V2 MASK BRACE