AccessGUDID - DEVICE: BD PhaSeal™ Optima Infusion Clamp M25-O (00382905150852)

GUDID

Device Identifier (DI) Information

Brand Name: BD PhaSeal™ Optima Infusion Clamp M25-O
Version or Model: 515085
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 515085
Company Name: BECTON DICKINSON PEN LIMITED

Primary DI Number: 00382905150852
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 988402590 *Terms of Use

Device Description: M25-O Infusion Clamp

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
63390	Intravenous line closed infusion system clamp	A non-sterile device in the form of a closable housing intended to enclose and secure the connection (e.g., Luer connection) between mating components of a closed infusion system [e.g., closed system drug transfer device (CSTD)] attached to a patient’s IV line to help prevent inadvertent separation of the closed infusion system components. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KMK	DEVICE, INTRAVASCULAR CATHETER SECUREMENT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: f1cd279d-8f34-45f7-b38f-31aaca97f4b5
Public Version Date: July 08, 2020
Public Version Number: 1
DI Record Publish Date: June 30, 2020