FDA.report

Mini-Spike®

Primary DI
04046964040900
Brand
Mini-Spike®
Company
B. BRAUN MEDICAL INC.
Model
412011
Catalog number
412011
Device description
Chemo Dispensing Pin™ with Dist al MINI-SPIKE® Plus
Published
2016-09-23
Public version status
Update
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
LHISet, i.V. Fluid transfer

Product Code Classifications

CodeDeviceSpecialtyClass
LHISet, I.V. Fluid TransferGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046964040900PackageGS12In Commercial Distribution
04046964040894PrimaryGS10
04046964040887Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964040900040469640409004046964040900
04046964040894040469640408944046964040894
04046964040887040469640408874046964040887

GMDN Terms

TermDefinition
Vial/bottle adaptor, non-hermeticA device intended to be fitted to a vial or bottle to enable the removal of its contents, (e.g., medication, nutritional solution for enteral feeding) into a syringe, for subsequent administration to a patient. It is typically a housing with a syringe connector that attaches to the container or replaces its lid; it does not allow for pressure equalization/airtight transfer of contents. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)227-2862BBMUS_Service.EmailOrders@bbraun.com

Regulatory Flags

DUNS number
002397347
Device count
50
DM exempt
false
Premarket exempt
false
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
false
Sterilization required before use
false

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