FDA.report

HHP,800,8FT,X,CURTAIN O/C,SHADES O/C

Primary DI
00840828120029
Brand
HHP,800,8FT,X,CURTAIN O/C,SHADES O/C
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
HHP800-046
Catalog number
17933
Device description
HHP,800,8FT,X,CURTAIN O/C,SHADES O/C
Published
2016-09-24
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

Related Records

Contact Domains

Product Codes

CodeName
FNLBed, Ac-Powered Adjustable Hospital
IQASystem, Environmental Control, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2
IQASystem, Environmental Control, PoweredPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840828120029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840828120029008408281200298408281200290840828120029

GMDN Terms

TermDefinition
Pillow speakerA loudspeaker intended to be used by a patient when lying in bed or resting in a chair by putting it close to their ear or between a pillow and their ear. It is typically designed as a small pillow-like device that contains a loudspeaker and that has a cable and a connector for connection to a radio, television, or other sound-emitting device with a Jack plug sound outlet. The sound level is regulated by the user with an adjustable control. It is typically used to create a relaxing atmosphere with music, for entertainment (e.g., to listen to the radio), and to aid sleep and relieve tinnitus.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-235-7500mwinter@curbell.com

Regulatory Flags

DUNS number
796452311
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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