DEVICE: BD PhaSeal™ Optima (00382905150579)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
BD PhaSeal™ Optima
515057
In Commercial Distribution
515057
BD Switzerland Sàrl
00382905150579
GS1

1
482631558 *Terms of Use
Injector (N40-O Multi)
CLOSE

Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
64467 Luer/non-ISO80369-standardized linear connector, single-use
A small, non-powered, noninvasive, tubular, two-way/linear connector with a Luer connection (either lock or slip) at one end and a connection which is not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases) at the other end (typically barbed, bayonet, collet, conical, threaded or non-Luer-slip) intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing or an external puncturing component. This is a single-use device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
ONB Closed antineoplastic and hazardous drug reconstitution and transfer system
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Keep away from sunlight
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
8fd1b425-5d42-436b-bfb2-d92f93808413
July 17, 2025
4
April 14, 2021
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
50382905150574 1 30382905150570 In Commercial Distribution Case
30382905150570 250 00382905150579 In Commercial Distribution Box
CLOSE

Secondary DI

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

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE