AccessGUDID - DEVICE: BD Cathena Safety IV Catheter (00382903868148)

GUDID

Device Identifier (DI) Information

Brand Name: BD Cathena Safety IV Catheter
Version or Model: 386814
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 386814
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382903868148
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 124987988 *Terms of Use

Device Description: CATHENA 22GX2.00IN WINGED BC

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	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?
64574	Peripheral intravenous cannula	A short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days

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
Special Storage Condition, Specify: Fragile, handle with care
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size = Catheter Gauge = 22 Gauge (G)
Length: 51 Millimeter
Device Size Text, specify: Flow Rate = 29 millilitre per minute (mL or ml/min)

Device Record Status

Public Device Record Key: b1e8dfc5-b02e-45df-911f-5a7f742a2a65
Public Version Date: July 30, 2025
Public Version Number: 3
DI Record Publish Date: October 22, 2018