FDA.report

AMFAB

Primary DI
00822383238197
Brand
AMFAB
Company
Drive Devilbiss Healthcare
Model
16011-UOQOV
Device description
Patient Room Overbed Tables Product Description OBT-Designer-QO-U-Opal-Van-Spcl
Published
2020-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
INWTABLE, MECHANICAL

Product Code Classifications

CodeDeviceSpecialtyClass
INWTable, MechanicalPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00822383238197PrimaryGS10

GMDN Terms

TermDefinition
Overbed tableA table designed to be moved directly over the bed of a patient/occupant to provide them with a surface to eat, read, or write while in bed. It is typically constructed as a C-shaped metal framework with a table top surface, on which objects are placed, and small Castor wheels to provide the mobility for moving it over the bed.

Sterilization Methods

Method

Regulatory Flags

DUNS number
867673159
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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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