AccessGUDID - DEVICE: BD Combined Spinal Epidural Tray (50382904008319)

GUDID

Device Identifier (DI) Information

Brand Name: BD Combined Spinal Epidural Tray
Version or Model: 400831
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 400831
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 50382904008319
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 001292192 *Terms of Use

Device Description: 27GX4 11/16IN WHIT,18GX3.5IN WEISS,CE

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":	Yes
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?
64348	Epidural/intrathecal anaesthesia set, medicated	A dual-purpose collection of devices intended for the administration of an analgesic or anaesthetic agent to the intrathecal space and to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent, and both a spinal needle and an epidural needle with additional devices utilized for the procedure (e.g., dressings, syringe), and may include an epidural catheter for continuous-administration. This is a single-use device.	Active	false

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: 66e90773-cf6f-42a0-96e9-031deddf9410
Public Version Date: September 11, 2023
Public Version Number: 1
DI Record Publish Date: September 02, 2023