FDA.report

Pillow Case

Primary DI
00616784816531
Brand
Pillow Case
Company
DYNAREX CORPORATION
Model
8165
Device description
Non-Woven Pillow Case 21"x30"
Published
2021-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
00616784816531PackageGS110In Commercial Distribution
00616784816517PrimaryGS10
00616784816500Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784816531006167848165316167848165310616784816531
00616784816517006167848165176167848165170616784816517
00616784816500006167848165006167848165000616784816500

GMDN Terms

TermDefinition
Basic pillowcase, reusableA protective envelope for a pillow typically made of a thin textile material that creates a physical barrier to soiling and cross-contamination. It does not include antimicrobial or dust mite barrier/prevention properties. The device is laundered for cleaning, usually at regular intervals. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
10
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
true
Sterilization required before use
false

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