AccessGUDID - DEVICE: BioFlo (H965460280)

GUDID

Device Identifier (DI) Information

Brand Name: BioFlo
Version or Model: 46-028
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NAVILYST MEDICAL, INC.

Primary DI Number: H965460280
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809699023 *Terms of Use

Device Description: BioFlo Midline with ENDEXO Technology (5F x 20cm, Single Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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
PND	Midline catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 20 Centimeter
Needle Gauge: 21 Gauge
Catheter Gauge: 5 French
Outer Diameter: 1.68 Millimeter
Pressure: 153 Pound per Square Inch

Device Record Status

Public Device Record Key: d25212cf-560e-4924-afd4-971b15026559
Public Version Date: March 25, 2024
Public Version Number: 5
DI Record Publish Date: June 04, 2019