AccessGUDID - DEVICE: BD Perisafe, BD Epilor, BD Luer-Lok, BD Glaspak (00382904058036)

GUDID

Device Identifier (DI) Information

Brand Name: BD Perisafe, BD Epilor, BD Luer-Lok, BD Glaspak
Version or Model: 405803
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 405803
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382904058036
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001292192 *Terms of Use

Device Description: TRAY CSE WHIT25G4.7 WE17G3.5 5ML GLS TIP

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:	Yes
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Epidural/intrathecal anaesthesia kit	A collection of sterile devices designed to deliver an analgesic or anaesthetic agent into the epidural and subarachnoid (intrathecal) spaces around the spinal cord for pain management. It typically includes a procedural needle(s), syringe, catheter(s), and filter(s), but does not include medication. This is a single-use device.

FDA Product Code

[?]

Product Code	Product Code Name
CAZ	Anesthesia conduction kit

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e2124380-146d-433f-9fca-d81dd6cf25a2
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 16, 2016