FDA.report

Bariatric Shower Chair with Back

Primary DI
00616784032115
Brand
Bariatric Shower Chair with Back
Company
DYNAREX CORPORATION
Model
10321
Published
2019-10-21
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
ILSAdaptor, Hygiene

Product Code Classifications

CodeDeviceSpecialtyClass
ILSAdaptor, HygienePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784032115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784032115006167840321156167840321150616784032115

GMDN Terms

TermDefinition
Shower seat, non-poweredA non-powered device designed to be sat upon by a patient (adult or child) while washing in a shower, or other washing facility (e.g., bath). The patient is typically disabled, infirm, or is undergoing medical treatment and requires to be seated while bathing/showering. The device may be in the form of a portable chair/stool or a fixed seat (e.g., wall-mounted), and may include armrests, side supports, or grab handles; it is typically made of water-resistant or waterproof materials (e.g., plastic and metal-coated materials). It may be used in a hospital, institution, or home.

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

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