Zephyr Patient Positioning and Transfer System

GUDID B237ZEPAUB700

Zephyr HDR Accessory - Universal Clamp Bracket for RPD Universal Clamp

DIACOR, INC.

Patient transfer system, powered

• Primary Device ID: B237ZEPAUB700
• NIH Device Record Key: 5e497576-93da-4d66-ac1d-5ac40e27e519
• Commercial Distribution Discontinuation: 2022-09-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Zephyr Patient Positioning and Transfer System
• Version Model Number: ZEP-AUB-70
• Company DUNS: 605813559
• Company Name: DIACOR, 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: false
• 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
HIBCC	B237ZEPAUB700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121929

FDA Product Code

• FRZ: Device, Patient Transfer, Powered

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: 2022-09-27
• Device Publish Date: 2022-09-19

On-Brand Devices [Zephyr Patient Positioning and Transfer System]

• B237ZXLZHP200: Zephyr HP PRO Head and Neck Hover System
• B237ZXLZHP100: Zephyr HP Head and Neck Hover System
• B237ZXLZGE100: Zephyr XL Patient Hover Board for GE MRI Scanners
• B237ZXLIRS100: Zephyr IR Transfer Board Skull Clamp Version
• B237ZXLIRN100: Zephyr IR-N Hover Board for neuro-related patient transfer
• B237ZXLIRG100: Zephyr IR Patient Transfer Board
• B237ZXL50: Zephyr XL Patient Hover Board LP
• B237ZXL40: Zephyr XL Patient Hover Board 50cm
• B237ZXL30: Zephyr XL Patient Hover Board 50cm w/ Gating Plate
• B237ZXL20: Zephyr XL Patient Hover Board for MedPhoton Imaging Tables
• B237ZXL10: Zephyr XL Patient Hover Board
• B237ZEPAPS010: Zephyr Accessory, Patient Stirrups with rail clamps
• B237ZEP30: Zephyr HDR Hover Board
• B237ZBL9MR0: Zephyr Blower Kit for 220v for ZTG-2 stretcher
• B237ZBL90: Zephyr Blower Kit for 220v for ZTG-4 stretcher
• B237ZBL8MR0: Zephyr Blower Kit for 110V, for ZTG-2 stretcher
• B237ZBL80: Zephyr Blower Kit for 110V, for ZTG-4 stretcher
• B237ZBL30: Zephyr Blower Kit for 110-120v, UL Listed
• B237ZBL24000: Zephyr Blower Kit for 220-240v, equipment boom mount
• B237ZBL23000: Zephyr Blower Kit for 220-240v, wall mount
• B237ZBL22000: Zephyr Blower Kit for 220-240v, procedural stretcher
• B237ZBL21000: Zephyr Blower Kit for 220-240v
• B237ZBL14000: Zephyr Blower Kit for 110-120v, equipment boom mount
• B237ZBL13000: Zephyr Blower Kit for 110-120v, wall mount
• B237ZBL12000: Zephyr Blower Kit for 110-120v, procedural stretcher
• B237ZBL11000: Zephyr Blower Kit for 110-120v
• B237ZXLIRS200: Zephyr IR-S Hoverboard with mounts for Skull Clamp for Philips MR. Includes the Zephyr IR-S Hov
• B237ZXLIRA100: Zephyr IR Articulating Hoverboard with mounts for skull clamp
• B237ZEPAUB610: Zephyr HDR Accessory - Universal Clamp Bracket for Varian Universal Clamp (Rev2)
• B237ZEPAUB600: Zephyr HDR Accessory - Universal Clamp Bracket for Varian Universal Clamp
• B237ZEPAUB530: Zephyr HDR Accessory - Universal Clamp Bracket for ELEKTA Universal Clamp (Rev2) - 3 screw mount
• B237ZEPAUB520: Zephyr HDR Accessory -Universal Clamp Bracket for ELEKTA Universal Clamp (Rev2) - 2 screw mount
• B237ZEPAUB510: Zephyr HDR Accessory - Universal Clamp Bracket for ELEKTA Universal Clamp - 3 screw mount design
• B237ZEPAUB500: Zephyr HDR Accessory -Universal Clamp Bracket for ELEKTA Universal Clamp - 2 screw mount design
• B237ZEPATS020: Zephyr HDR Accessory - Trumpf Table Kit End Stop, radiolucent version
• B237ZEPATS010: Zephyr HDR Accessory - Trumpf Table Kit
• B237ZEPAAS010: Zephyr HDR Accessory - Arcoma Table Kit. Includes end stop and extended guide rails for use wit
• B237ZEP40: Zephyr HDR Hover Board
• B237ZXLASR110: GE GEM MR Cart Strain Relief for Zephyr & Mayfield Skull Clamp
• B237ZXLASR100: GE GEM MR Cart Strain Relief for Zephyr & DORO Skull Clamp
• B237ZXLASB060: Zephyr Docking Side Stop Bar - (1): Used on GE SIGNA PET/MR FTT for Zephyr Systems
• B237ZXLASB050: Zephyr Docking Side Stop Bar - (1): Used on Philips Ingenia MR-SIM
• B237ZXLASB040: Zephyr Docking Side Stop Bar - (1): Used on 50cm Non-Indexed Couch
• B237ZXLASB030: Zephyr Docking Side Stop Bar - (1): Used on 53cm Elekta iBeam Couch
• B237ZXLASB020: Zephyr Docking Side Stop Bar for 50cm XL - (1): Used on 53cm Varian Couch
• B237ZXLASB010: Zephyr Docking Side Stop Bar - (1): Used on 53cm Varian Couch
• B237ZXLAOT150: OTP (Over-travel protection) solution kit for Hillrom/Trumpf Carbon Floatline
• B237ZXLAOT140: OTP (Over-travel protection) solution kit for Canon Angio Imaging Tables
• B237ZXLAOT130: OTP (Over-travel protection) solution kit for Trumpf Hybrid Carbon Fiber Table Top
• B237ZXLAOT120: OTP (Over-travel protection) solution kit for GE Omega or IQ Tilt Tables