AccessGUDID - DEVICE: N/A (00382903033690)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 303369
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 303369
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382903033690
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 124987988 *Terms of Use

Device Description: Threaded Lock Cannula

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?
60538	Luer/Luer linear connector, single-use	A small, non-powered, noninvasive tubular, two-way/linear connector with a Luer connection (either lock or slip) at both ends 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 nor puncturing component. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMI	Needle, hypodermic, single lumen
FPA	Set, administration, intravascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K011858	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 00316a6f-290d-4f1b-9346-8b7d88425d8c
Public Version Date: July 13, 2023
Public Version Number: 4
DI Record Publish Date: September 16, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50382903033695	1000	00382903033690		In Commercial Distribution	Case
30382903033691	100	00382903033690		In Commercial Distribution	Box

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: Yes
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

[?]

Phone: +1(844)823-5433
Email: customer_support@bd.com

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