FDA.report

Disposable Grey Blanket

Primary DI
00616784353937
Brand
Disposable Grey Blanket
Company
DYNAREX CORPORATION
Model
3539
Device description
Disposable Grey Blaket 100% Polyester, 40"x80"
Published
2021-09-01
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
true

Related Records

Product Codes

CodeName
KMEBedding, Disposable, Medical

Product Code Classifications

CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784353937PackageGS124In Commercial Distribution
00616784353913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784353937006167843539376167843539370616784353937
00616784353913006167843539136167843539130616784353913

GMDN Terms

TermDefinition
Bed blanket, single-useA large piece of fabric or fabric-like material used to cover a patient/person to insulate body heat for warmth. It is typically used as a bed covering, but may be used for other purposes (e.g., as a wrap for warmth and comfort). This device is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated).

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
true
Sterilization required before use
false

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