FDA.report

MEDLINE

Primary DI
40889942822639
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDA2214
Catalog number
DYNDA2214
Device description
STERILE BABY BLANKET
Published
2022-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KMEBEDDING, DISPOSABLE, MEDICAL

Product Code Classifications

CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40889942822639PackageGS150In Commercial Distribution
10889942822638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4088994282263940889942822639
1088994282263810889942822638

GMDN Terms

TermDefinition
Infant blanket, reusableA piece of fabric material intended to be used to wrap newborns/infants to retain their body heat. Commonly known as a baby blanket, it is available in a variety of fabrics (e.g., wool, cotton, or synthetic materials) and textures (e.g., cellular or smooth). This is a reusable device after appropriate cleaning.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463CUSTOMERSERVICE@MEDLINE.COM

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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20884389108229MEDLINENONLV200XXLNONLV200XXL2025-05-27
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