AccessGUDID - DEVICE: B.BRAUN (04046964310669)

GUDID

Device Identifier (DI) Information

Brand Name: B.BRAUN
Version or Model: 613403
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 613403
Company Name: B BRAUN INTERVENTIONAL SYSTEMS, INC

Primary DI Number: 04046964310669
Issuing Agency: GS1
Commercial Distribution End Date: July 11, 2016
Device Count: 5
Labeler D-U-N-S® Number*: 784259751 *Terms of Use

Device Description: 5F PICC SINGLE 55 NITGLD130 CTS555-NG130

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36257	Peripherally-inserted central venous catheter	A thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LJS	Catheter,intravascular,therapeutic,long-term greater than 30 days

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K083873	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: KEEP DRY
Special Storage Condition, Specify: ROOM TEMP
Special Storage Condition, Specify: KEEP AWAY FROM SUNLIGHT.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Length of catheter : 55.000 CM
Catheter Gauge: 5.00 French
Device Size Text, specify: Length of guidewire : 130.000 CM

Device Record Status

Public Device Record Key: 0d943d51-7c72-493a-89da-34a1d85f47ad
Public Version Date: November 02, 2022
Public Version Number: 7
DI Record Publish Date: July 22, 2015