FDA.report

Full Bed Rail Bumper, 1 Pair

Primary DI
00616784300412
Brand
Full Bed Rail Bumper, 1 Pair
Company
DYNAREX CORPORATION
Model
13004
Published
2022-05-09
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
KMEBedding, Disposable, Medical

Product Code Classifications

CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784300443PackageGS15In Commercial Distribution
00616784300412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784300443006167843004436167843004430616784300443
00616784300412006167843004126167843004120616784300412

GMDN Terms

TermDefinition
Bedrail padA device which is formed as a flat or contoured fitted cushion made of soft, non-irritating materials designed to protect the patient from coming into contact with the bedrails and inadvertently hurting or injuring themselves. It will be mainly used for patients that have little self-control, infants and very young children. This is a reusable 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
false
Serial number
false
Manufacturing date on label
false
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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