Device
3mL ENFit Low Dose Tip Syringe - Amber Bulk Non-sterile
Manufacturer
Vesco Medical, LLC
Model: VED-603ABR DI: 00810096151865 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-05-20 Current Version: 2026-05-28
Description
3mL ENFit Low Dose Tip Syringe - Amber Bulk Non-sterile
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: ebda6b80-21e7-4a1c-9a00-00bf807a3633
Distribution Status: In Commercial Distribution
DUNS Number: 119007223
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: Yes
Identifiers
Item #1 - Pkg Type: inner pack
Item #1 - Device ID: 10810096151862
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 100
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 00810096151865
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00810096151865
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
Item #3 - Pkg Type: case
Item #3 - Device ID: 20810096151869
Item #3 - Pkg Status: In Commercial Distribution
Item #3 - Pkg Quantity: 5
Item #3 - Device ID Type: Package
Item #3 - Contains DINumber: 10810096151862
Item #3 - Device ID Issuing Agency: GS1
Item #4 - Pkg Type: shipper
Item #4 - Device ID: 30810096151866
Item #4 - Pkg Status: In Commercial Distribution
Item #4 - Pkg Quantity: 8
Item #4 - Device ID Type: Package
Item #4 - Contains DINumber: 20810096151869
Item #4 - Device ID Issuing Agency: GS1
GMDN
Code: 62001
Name: ENFit oral/enteral syringe, reusable
Definition:
A manual device intended to be used for the administration of oral medication or delivery of enteral nutrition by connection to an enteral administration device. It consists of a calibrated hollow barrel (cylinder) and a moveable plunger intended to be operated by a healthcare provider or parent device. The tip is designed to mate only with enteral administration devices (i.e., ENFit) and is incompatible with Luer connectors; 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 reusable device.
FDA Product Codes
PNR
Enteral Syringes With Enteral Specific Connectors
Premarket Submissions
Submission Number: K253268
Supplement Number: 000
Device Sizes
Device Size - Size - @attributes - Unit: Milliliter
Device Size - Size - @attributes - Value: 3
Device Size - Size Type: Total Volume