AccessGUDID - DEVICE: NeoConnect Oral / Enteral Syringe, OTC (00817584013209)

GUDID

Device Identifier (DI) Information

Brand Name: NeoConnect Oral / Enteral Syringe, OTC
Version or Model: Neo3
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Neo3
Company Name: NEOMED, INC.

Primary DI Number: 00817584013209
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 799772079 *Terms of Use

Device Description: 3mL NeoConnect Enteral Syringe with ENFit Connector, Non-Sterile, OTC

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
62001	ENFit oral/enteral syringe, reusable	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PNR	Enteral Syringes With Enteral Specific Connectors

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3b6c2085-f5b4-4ef9-a8e5-7e03146b2f34
Public Version Date: October 29, 2021
Public Version Number: 3
DI Record Publish Date: September 06, 2019