Biostep 2, 100-240 VAC

GUDID 00718175002407

950-240 Biostep 2, 100-240 VAC

BIODEX MEDICAL SYSTEMS, INC.

Bicycle ergometer
Primary Device ID00718175002407
NIH Device Record Keya4ab848d-7d52-4747-aeec-bd0313e9f570
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiostep 2, 100-240 VAC
Version Model Number950-240
Company DUNS043833813
Company NameBIODEX MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100718175002407 [Primary]

FDA Product Code

BXBExerciser, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-14
Device Publish Date2024-05-06

Devices Manufactured by BIODEX MEDICAL SYSTEMS, INC.

00718175002407 - Biostep 2, 100-240 VAC2024-05-14950-240 Biostep 2, 100-240 VAC
00718175002407 - Biostep 2, 100-240 VAC2024-05-14 950-240 Biostep 2, 100-240 VAC
00718175006009 - Reactive Step Trainer 115V2024-05-14 950-600 Reactive Step Trainer 115V
00718175001462 - Biodex2023-08-10 CYCLE, UPPER BODY
00718175001486 - Biodex2023-08-10 CYCLE, UPPER BODY - CLINICAL PRO
00718175005606 - Sit2Stand2023-08-08 SIT2STAND SQUAT-ASSIST TRAINER
00718175004302 - VibroTactile2023-07-27 VIBROTACTILE BELT KIT
00718175087640 - BETA, Syringe Shield 2021-01-15 BETA, Lead Encapsulated Syringe Shield, 20cc
00718175087626 - VENTI-SCAN IV2020-10-23 Venti-Scan IV, Includes shielded canister with IV pole mount
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