FDA.reportPublic FDA data

Zephyr Patient Positioning and Transfer System

Primary DI
B237ZXLASB020
Brand
Zephyr Patient Positioning and Transfer System
Company
Diacor, Inc.
Model
ZXL-ASB-02
Device description
Zephyr Docking Side Stop Bar for 50cm XL - (1): Used on 53cm Varian Couch
Published
2021-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LHNSystem, Radiation Therapy, Charged-Particle, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHNSystem, Radiation Therapy, Charged-Particle, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121929000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121929000ZEPHYR 'X-SERIES PATIENT TRANSFER SLEDDiacor, Inc.2013-01-17FRZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B237ZXLASB020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Patient transfer system, poweredA mains electricity (AC-powered) assembly of devices used to transfer a supine patient, typically from his/her bed or transport stretcher to an operating table or vice versa. It is usually installed in large operating room (OR) complexes and serves as a sluice providing demarkation between the OR staff and the ward staff/porters and related devices. It may be designed as a motorized belt that is wider than the length of the patient and that rotates around a moveable pick-up plate which feeds in under the patient, drawing him/her onto the belt and depositing him/her onto an adjacent surface. It is typically fully automated, requiring no human intervention other than to operate the controls.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
801-467-0050Sales@DiacorInc.com

Regulatory Flags#

DUNS number
605813559
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B237ZEPACR110Zephyr Patient Positioning and Transfer SystemZEP-ACR-112025-12-23
B237ZCPAST100Zephyr Patient Positioning and Transfer SystemZCP-AST-102025-11-13
B237ZEPAUB800Zephyr Patient Positioning and Transfer SystemZEP-AUB-802025-09-26
B237ZEPATG030Zephyr Patient Positioning and Transfer SystemZEP-ATG-032025-08-13
B237ZEPAFR200Zephyr Patient Positioning and Transfer SystemZEP-AFR-202023-06-12
B237ZBL25000Zephyr Patient Positioning and Transfer SystemZBL-2-5002024-07-11
B237ZEPAPS100Zephyr Patient Positioning and Transfer SystemZEP-APS-102024-07-11
B237ZEPAPS110Zephyr Patient Positioning and Transfer SystemZEP-APS-112024-07-11
B237ZEPAPS120Zephyr Patient Positioning and Transfer SystemZEP-APS-122024-07-11
B237ZEPAPS500Zephyr Patient Positioning and Transfer SystemZEP-APS-502024-07-11
B237ZEPASC010Zephyr Patient Positioning and Transfer SystemZEP-ASC-012024-07-11
B237ZEPASC100Zephyr Patient Positioning and Transfer SystemZEP-ASC-102024-07-11
B237ZEPASC500Zephyr Patient Positioning and Transfer SystemZEP-ASC-502024-07-11
B237ZXLACA100Zephyr Patient Positioning and Transfer SystemZXL-ACA-102024-07-11
B237ZXLACI150Zephyr Patient Positioning and Transfer SystemZXL-ACI-152024-07-11
B237ZXLACI160Zephyr Patient Positioning and Transfer SystemZXL-ACI-162024-07-11
B237ZXLADK040Zephyr Patient Positioning and Transfer SystemZXL-ADK-042024-07-11
B237ZBLABF010Zephyr Patient Positioning and Transfer SystemZBL-ABF-012023-06-12
B237ZBLAWP010Zephyr Patient Positioning and Transfer SystemZBL-AWP-012023-06-12
B237ZBLHIN100Zephyr Patient Positioning and Transfer SystemZBL-HIN-102023-06-12

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Primary DI, Brand, Company table
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