AccessGUDID - DEVICE: Insyte Autoguard BC Pro (00382903925346)

GUDID

Device Identifier (DI) Information

Brand Name: Insyte Autoguard BC Pro
Version or Model: 392534
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 392534
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382903925346
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 124987988 *Terms of Use

Device Description: IAG BC PRO PNK 20GA X 1.16IN

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":	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?
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 [?]
K201075	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: Fragile, handle with care
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
Length: 1.16 Inch
Device Size Text, specify: Size = Catheter Gauge = 20 Gauge (G)
Device Size Text, specify: Flow Rate = 61 millilitre per minute (mL or ml/min)

Device Record Status

Public Device Record Key: 3def1472-a23f-4f92-ab81-9b439747eca6
Public Version Date: July 29, 2025
Public Version Number: 3
DI Record Publish Date: September 02, 2021