FDA.report

NA

Primary DI
04046964317064
Brand
NA
Company
B. BRAUN MEDICAL INC.
Model
622230
Catalog number
622230
Device description
FCS1300 RADIOL DUAL-LINE SET
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
IZISystem, x-ray, angiographic

Product Code Classifications

CodeDeviceSpecialtyClass
IZISystem, X-Ray, AngiographicRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046964317064PrimaryGS10
04046964317040Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964317064040469643170644046964317064
04046964317040040469643170404046964317040

GMDN Terms

TermDefinition
Fluid transfer set, general-purposeA collection of sterile devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. 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
25
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
true
Sterilization required before use
false

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