AccessGUDID - DEVICE: BD Intelliport (00382905167041)

GUDID

Device Identifier (DI) Information

Brand Name: BD Intelliport
Version or Model: 516704
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 516704
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382905167041
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001292192 *Terms of Use

Device Description: KIT TABLET

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?
65031	Intravenous injection automated detection/documentation system computer	An electronic component of an intravenous (IV) injection automated detection/documentation system, intended to electronically receive IV bolus injection data (time, drug, dosage) from the system processor/transmitter and document the data [e.g., within the electronic health record (EHR)] as part of automatic detection/documentation of patient anaesthesia dosing. It includes a monitor and keyboard (e.g., in the form of a touchscreen tablet) with wireless connectivity, and dedicated system software. Data that is documented includes drug name, volume, and concentration (dose), and time of dose administration.	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: c079b376-bd68-4279-8617-f27fb4813201
Public Version Date: October 08, 2020
Public Version Number: 1
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: No Unit of Use DI Numbers Found 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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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