FDA.report

Super Bariatric Elevating Leg Rest ELR (for 26",28",30"WC)

Primary DI
00616784026411
Brand
Super Bariatric Elevating Leg Rest ELR (for 26",28",30"WC)
Company
DYNAREX CORPORATION
Model
10264
Published
2019-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IMMFootrest, Wheelchair

Product Code Classifications

CodeDeviceSpecialtyClass
IMMFootrest, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784026411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784026411006167840264116167840264110616784026411

GMDN Terms

TermDefinition
Wheelchair legrestA platform (typically metal with or without a padded vinyl covering) usually mounted on a wheelchair in pairs, and upon which a wheelchair occupant may place the legs for comfort, support, and/or to keep them off of the ground. The device may be fixed or adjustable. This GMDN code will also include the extensions needed to fit this device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00616784710518Sphygmomanometer71052016-09-24
00616784710617Sphygmomanometer71062016-09-24
00616784711027Single Head Stethoscope, Single Head71102021-04-22
00616784711126Stethoscope Dual Head71112021-04-22
00616784711225PA SensiLance Pressure Activated Safety Lancets, Sterile71122021-05-21
00616784711423PA [SensiLance Pressure Activated Safety Lancets,Sterile71142021-05-21
00616784709833Blood Pressure Cuff Kits, Sphygmomanometer, 5-Cuffs, Infant, Child, Adult, Large70982017-11-21
00616784709529Digital Blood Pressure Monitor70952021-01-19
00616784709628Digital Blood Monitors70962021-01-19
00616784709925Blood Pressure Kit,Sphymomanometer with Dual Head Stethoscope70992016-09-24
00616784710020Blood Pressure Kit Sphygmomanometer with Stethoscope71002016-09-24
00616784710228Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71022016-09-24
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310612026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310622026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, 10 FR (3.3 mm)310632026-05-25
00840117349711IV Extension Sets Needle-Free Luer Lock Connector For Injection, Non-Toxic, 17"70612016-09-24
00840117349742IV Extension Sets Needle-Free Luer Lock Connector, Non-Toxic, 8" (20.3 cm)70622016-09-24
00616784706313IV Extension Sets Needle-Free Luer Lock Connector for Injection Non-Toxic70632024-03-25

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10810041984613ViveVIVE HEALTH LLCIMM2024-09-03
00841447114970HEMI SMT ART LGRST COMP FTPLT FOR 16-24WINVACARE CORPORATIONIMM2024-07-25
00841447114987EC HEMI ELEV LGRST NO-PAD CLF COMP FTPLTINVACARE CORPORATIONIMM2024-07-25
00841447114994HEMI SMART LEG ART.LEGS-ALUMINVACARE CORPORATIONIMM2024-07-25
80193489019314MedlineMEDLINE INDUSTRIES, INC.IMM2024-06-14
10193489019346MedlineMEDLINE INDUSTRIES, INC.IMM2024-03-05
00092237600504Roscoe MedicalCOMPASS HEALTH BRANDS CORP.IMM2024-02-28
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00092237624197ProBasicsCOMPASS HEALTH BRANDS CORP.IMM2023-07-25
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07540147002275Basic (Rubber Coated) Foot Platform MountMotion Concepts IncIMM2022-12-08
07540147002282Standard Flip-Up Foot PlatformMotion Concepts IncIMM2022-12-08
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07540147002824CM Legrest, Multi-Axis Independent Footplate MountMotion Concepts IncIMM2022-12-08
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