Home GUDID 00810113680170 ManaMed
Primary DI 00810113680170
Brand ManaMed
Company Manamed, Inc.
Model Bionic Sling Air Shoulder
Catalog number BS001
Device description The Bionic Sling is a universal shoulder sling with a continuous passive machine to promote small movements after shoulder surgeries to help patients recover quicker.Features and BenefitsUniversal sizing and can be applied to the left or right sideBreathable material for patient comfortProvides support for shoulder surgeries or conservative care of shoulder injuriesPassive MachineThe pneumatic passive machine included with the shoulder slingTo be worn to promote abduction movement with internal and external rotationAbility to achieve various abduction angles from 30 to 90 degreesThe machine is portable, wireless, and rechargeableCommon Examples of UseTo promote small movements after rotator cuff, arthroscopic, and anterior repairsTo prevent frozen shoulderShoulder instabilitiesTo be worn to eliminate the need for contracture braces
Published 2022-06-20
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
Product Codes# Code, Name table Code Name ILI Sling, Arm
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ILI Sling, Arm Physical Medicine 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810113680170 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00810113680170 00810113680170 810113680170 0810113680170
GMDN Terms# Term, Definition table Term Definition Shoulder immobilizer/orthosis, reusable A prefabricated (non-customized) non-rigid wearable device designed to support, align, and/or temporarily immobilize the shoulder joint to support the healing of an injury or surgical wound. It will typically consist of straps, buckles, fasteners, or be in the form of a sling. This is a reusable device.
Regulatory Flags# DUNS number 084042331 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810113682730 ManaSlide MSLIDE MSLIDE01 2025-11-25 00810113688473 ManaMed Inc ManaMed Ultrasound Coupling Gel MANAGEL01 2022-12-31 00810113684154 ManaEZ Wrist Left, Extra Large EZW3908L-XL EZW3908L-XL 2025-10-17 00810113684161 ManaEZ Wrist Left, Extra Small EZW3908L-XS EZW3908L-XS 2025-10-17 00810113684178 ManaEZ Wrist Right, Extra Large EZW3908R-XL EZW3908R-XL 2025-10-17 00810113684185 ManaEZ Wrist Right, Extra Small EZW3908R-XS EZW3908R-XS 2025-10-17 00810113682969 "ManaEZ Single Panel Knee Immobilizer 18""" EZIMM01-18 EZIMM01-18 2025-11-25 00810113682976 "ManaEZ Single Panel Knee Immobilizer 20""" EZIMM01-20 EZIMM01-20 2025-11-25 00810113682983 "ManaEZ Single Panel Knee Immobilizer 24""" EZIMM01-24 EZIMM01-24 2025-11-25 00810113682990 "ManaEZ 3 Panel Knee Immobilizer 18""" EZ3PIMM01-18 EZ3PIMM01-18 2025-11-25 00810113683003 "ManaEZ 3 Panel Knee Immobilizer 20""" EZ3PIMM01-20 EZ3PIMM01-20 2025-11-25 00810113683010 "ManaEZ 3 Panel Knee Immobilizer 24""" EZ3PIMM01-24 EZ3PIMM01-24 2025-11-25 00810113683294 "ManaEZ 3 Panel Knee Immobilizer 16""" EZ3PIMM01-16 EZ3PIMM01-16 2025-11-25 00810113682600 ManaMed Inc ManaEZ Ice Wrist EZIWST01 2022-10-13 00850998008119 ManaMed ManaEZ Wrist Universal Right EZW3908R 2022-06-20 00850998008126 ManaMed ManaEZ Wrist Universal Left EZW3908L 2022-06-20 00810113683065 ManaEZ ROM Ice Short EZR001-XSM EZR001-XSM 2025-10-17 00810113683515 ManaEZ Hip Ice CureTech EZHIP01B-CT EZHIP01B-CT 2025-10-03 00810113683522 ManaEZ ROM Ice CureTech EZR001-CT EZR001-CT 2025-10-03 00810113683539 ManaEZ Shoulder Ice CureTech EZSHLD-CT EZSHLD-CT 2025-10-03
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00749756880282 DeRoyal DEROYAL INDUSTRIES, INC. ILI 2026-04-02 00749756880299 DeRoyal DEROYAL INDUSTRIES, INC. ILI 2026-04-02 00749756880312 DeRoyal DEROYAL INDUSTRIES, INC. ILI 2026-04-02 00749756880329 DeRoyal DEROYAL INDUSTRIES, INC. ILI 2026-04-02 00749756880336 DeRoyal DEROYAL INDUSTRIES, INC. ILI 2026-04-02 00749756880343 DeRoyal DEROYAL INDUSTRIES, INC. ILI 2026-04-02 00749756880930 DeRoyal DEROYAL INDUSTRIES, INC. ILI 2026-04-02 00749756880947 DeRoyal DEROYAL INDUSTRIES, INC. ILI 2026-04-02 00749756880954 DeRoyal DEROYAL INDUSTRIES, INC. ILI 2026-04-02 00749756880961 DeRoyal DEROYAL INDUSTRIES, INC. ILI 2026-04-02 06974500613616 Arm Sling GCMEDICA ENTERPRISE LTD.(WUXI) ILI 2025-12-12 06974500613623 Arm Sling GCMEDICA ENTERPRISE LTD.(WUXI) ILI 2025-12-12 16974500613613 Arm Sling GCMEDICA ENTERPRISE LTD.(WUXI) ILI 2025-12-12 16974500613620 Arm Sling GCMEDICA ENTERPRISE LTD.(WUXI) ILI 2025-12-12 00810113683041 Kangaroo 3960 Manamed, Inc. ILI 2025-10-17 00810113683027 Shoulder Brace with Airplane Kit Manamed, Inc. ILI 2025-09-19 00810113683034 Shoulder Brace with Airplane Kit LOGO Manamed, Inc. ILI 2025-09-19 00190446660354 PROCARE DJO, LLC ILI 2025-07-14 00749756397841 DeRoyal DEROYAL INDUSTRIES, INC. ILI 2025-02-27 50749756397846 DeRoyal DEROYAL INDUSTRIES, INC. ILI 2025-02-27 00749756397285 DeRoyal DEROYAL INDUSTRIES, INC. ILI 2025-02-13 00840314811097 UNIV ARM SLING W/FOAM STRAP ADULT Hausmann Enterprises, LLC ILI 2025-01-01 M68932600100 Cravat Safeguard US Operating, LLC ILI 2024-10-09 00810113576947 CoreTech VIVE HEALTH LLC ILI 2024-06-10 10810113576944 CoreTech VIVE HEALTH LLC ILI 2024-06-10 00057475611026 BIOS Living Thermor Ltd ILI 2024-05-23 10057475611023 BIOS Living Thermor Ltd ILI 2024-05-23 00888912014366 DONJOY DJO, LLC ILI 2024-02-27 07798094540061 WELLBRACE PANTYMED S.A. ILI 2024-01-05 07798094540078 WELLBRACE PANTYMED S.A. ILI 2024-01-05