AccessGUDID - DEVICE: BD Intelliport (50382905167015)

GUDID

Device Identifier (DI) Information

Brand Name: BD Intelliport
Version or Model: 516701
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 516701
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 50382905167015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 001292192 *Terms of Use

Device Description: BASE

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
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
Special Storage Condition, Specify: Room Temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 393c7ecc-323a-423f-9835-8301ee1655f5
Public Version Date: October 08, 2020
Public Version Number: 1
DI Record Publish Date: September 30, 2020