FDA.report

Perifix®

Primary DI
04046964178986
Brand
Perifix®
Company
B. BRAUN MEDICAL INC.
Model
332285
Catalog number
332285
Device description
PERIFIX® Catheter Conn ector - use with PERIFIX® 19 Ga.
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
BSOCATHETER, CONDUCTION, ANESTHETIC

Product Code Classifications

CodeDeviceSpecialtyClass
BSOCatheter, Conduction, AnestheticAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046964178986PrimaryGS10
04046964178979Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964178986040469641789864046964178986
04046964178979040469641789794046964178979

GMDN Terms

TermDefinition
NRFit/non-ISO80369-standardized linear connectorA small, non-powered, noninvasive, tubular, two-way/linear connector with an NRFit connection (designed according to ISO 80369-6 for neuraxial applications) at one end and a connection which is not designed according to ISO 80369 at the other end (typically barbed, conical, threaded or non-Luer-slip), intended to connect a neuraxial device (e.g., epidural catheter, syringe) with an NRFit connection typically with tubing. It does not have a Luer connection(s), and does not incorporate a filter, valve, clamp nor tubing. 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
true
Sterilization required before use
false

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04046964525728Extension Set4903164903162016-09-23
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04046955745753Introcan Safety ® 24242001-024242001-022025-12-19
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