FDA.reportPublic FDA data

Bariatric HD Elevating Leg Rest (for 26", 28", 30", 32" WC)

Primary DI
00616784026411
Brand
Bariatric HD Elevating Leg Rest (for 26", 28", 30", 32" WC)
Company
Dynarex Corporation
Model
10264
Published
2019-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IMMFootrest, Wheelchair
KNNComponents, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMMFootrest, WheelchairPhysical Medicine1
KNNComponents, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784026411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784026411006167840264116167840264110616784026411

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair footrest/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 feet/legs for comfort, support, and/or to keep them off of the ground. It typically includes a mounting frame, footrest, and may include a mounted pad(s) to support the calves of the legs; it may be fixed or adjustable.

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
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00840117305359Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500301062021-04-22
00840117305373Resp-O2 Hygroscopic Condenser Humidifier HMEF 600301072021-04-22
00840117305397Resp-O2 Heat Moisture Exchange (HMEF) 1500 + (HEPA) Filter301122021-04-22
00840117305410Resp-O2 Heat Moisture Exchanger (HME) 1500, Adult302012021-04-22
00840117305434Resp-O2 Heat Moisture Exchanger (HME) 1500, Adult, HCH, CO2 Port302032021-04-22
00840117305458Resp-O2 Heat Moisture Exchanger (HME) 1500, HCH, CO2 Port, Flex Tube302042021-04-22
00840117305472Resp-O2 Heat Moisture Exchanger (HME) 600, HCH, CO2 Port, Pediatric302052021-04-22
00840117305496Resp-O2 Pediatric/Neonatal Mini Tracheostomy (HME) 50302102021-04-22
00840117305557Resp-O2 Heat Moisture Exchanger (HME) 1250 Tracheostomy303022021-04-22
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00840117318113Resp-O2 Heat Moisture Exchanger (HME) 1500 Tracheostomy303032021-04-22
00840117318137Resp-O2 Heat Moisture Exchanger (HME) 1500 Tracheostomy303052021-04-22
00840117305519Resp-O2 Heat Moisture Exchanger (HME) 1250 Tracheostomy303002022-05-10
00840117305533Resp-O2 Heat Moisture Exchanger (HME) 1250 Tracheostomy303012022-05-10
00840117313545Resp-O2 Disposable Suction Canisters, 800 cc, Float Valve Shutoff, Locking Lid322012022-04-28
00840117305274Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1500301012021-04-22

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