Resources
Documents your value analysis committee will ask for.
Catalog, instructions for use and regulatory identifiers, all in one place. Certificates of insurance, W-9s and vendor packets are available on request.
Zenith 11 Medical product catalog
Every product line with features, reference numbers and sizes.
PDF · 5 MBPush-Click Y Connector Kit, instructions for use
Indications, operation of the push-click valve, warnings and precautions.
PDF · 0.8 MBRadial Artery Compression Device, instructions for use
Placement, compression and stepwise decompression protocol for the rotary device.
PDF · 12 MBRegulatory identifiers
Use these to verify Zenith 11 Medical and its devices in the FDA establishment registration and device listing database.
- FDA establishment registration
- 3031282706
- FDA owner/operator number
- 10090757
- Establishment type
- Repackager / Relabeler
- Introducer sheath kits
- Product code DYB, listing D577326, 510(k) K222184
- Radial artery compression device
- Product code DXC, listing D576827, 510(k) K222182
- Y connectors, manifolds, stopcocks
- Product code DTL, listing D577325, 510(k) exempt
- Arm support board
- Product code NOD, listing D577327
- Manufacturer
- Beijing Demax Medical Technology Co., Ltd.
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