FDA.reportPublic FDA data

Brineura Administration Kit

Primary DI
00368135002000
Brand
Brineura Administration Kit
Company
BIOMARIN PHARMACEUTICAL INC.
Model
71098
Published
2018-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00368135002000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00368135002000003681350020003681350020000368135002000

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous medicine administration kit, non-medicated, single-useA collection of sterile devices intended to be used to administer various types of medication (non-dedicated) by injection. It will typically contain a syringe, a needle, extension tubing, adaptors, and antiseptic applicator, but not the medication. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
010004135
Device count
1
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true