AccessGUDID - DEVICE: BD Intelliport (50382905167008)

GUDID

Device Identifier (DI) Information

Brand Name: BD Intelliport
Version or Model: 516700
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 516700
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 50382905167008
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 001292192 *Terms of Use

Device Description: SENSOR

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:	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?
65029	Intravenous line sensor, anaesthesia injection	A noninvasive electronic component of an intravenous (IV) injection automated detection/documentation system, intended to be connected between an IV line and a medication syringe to measure the volume of anaesthesia medication administered as bolus injection to the patient, for subsequent patient dosing documentation. It includes an electronic sensor to a lumen/fluid path, Luer connectors at each end, and is intended to electronically interface with the system processor (not included), which collects and processes the raw sensory data. This is a single-use 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: Yes
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: 7ffdf43e-978e-4b2b-9902-943b8730fe3e
Public Version Date: April 18, 2025
Public Version Number: 2
DI Record Publish Date: September 30, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00382905167003 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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