AccessGUDID - DEVICE: BD Intelliport System (00382905168017)

GUDID

Device Identifier (DI) Information

Brand Name: BD Intelliport System
Version or Model: 516801
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 516801
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382905168017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001292192 *Terms of Use

Device Description: SYRINGE LABELER LUER LABEL CASSETTE

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
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?
65030	Intravenous injection automated detection/documentation system processor/transmitter	A noninvasive electronic component of an intravenous (IV) injection automated detection/documentation system, intended to electronically interface with a system sensor to: 1) provide power to, and extract IV bolus injection volume data from, the sensor; and 2) process and wirelessly transmit data to a computer as part of automatic detection/documentation of patient anaesthesia dosing. It is typically designed as a sensor base with a processor and wireless transmitter; it might include a barcode reader (for encoded syringe scanning) and an internal clock (for time of dose data collection). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPA	Set, administration, intravascular
PHC	Infusion safety management software

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0dd4a5a8-3ed2-4449-b2e8-75b1ec2d0b18
Public Version Date: November 14, 2025
Public Version Number: 2
DI Record Publish Date: June 07, 2024