AccessGUDID - DEVICE: BD Oral Syringe (30382903052104)

GUDID

Device Identifier (DI) Information

Brand Name: BD Oral Syringe
Version or Model: 305210
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 305210
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382903052104
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 001292192 *Terms of Use

Device Description: SYRINGE ORAL 3ML AMBER

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?
65823	Non-ISO80369-3-standardized oral syringe	A manual device consisting of a calibrated hollow barrel (cylinder) and a moveable plunger intended for the administration of oral medication. The tip is not formatted according to the standard for small-bore connectors for enteral applications (ISO 80369-3) [I.e., not ENFit], however the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYW	CONTAINER, LIQUID MEDICATION, GRADUATED

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: Keep dry
Special Storage Condition, Specify: Fragile, handle with care
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Room Temperature

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 3 Milliliter

Device Record Status

Public Device Record Key: ec5d1f0a-4fd5-46c5-b4da-99e27ba3a031
Public Version Date: August 01, 2025
Public Version Number: 3
DI Record Publish Date: September 02, 2023