AccessGUDID - DEVICE: Baxter Sterile Enteral Syringe with ENFit® Connector (00350770001579)

GUDID

Device Identifier (DI) Information

Brand Name: Baxter Sterile Enteral Syringe with ENFit® Connector
Version or Model: H93889005
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H93889005
Company Name: Avanos Medical, Inc.

Primary DI Number: 00350770001579
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079375431 *Terms of Use

Device Description: H93889005 0.5mL Bax ENFit Syringe Purp Sterile

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:	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?
59040	ENFit oral/enteral syringe, single-use	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 single-use 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 [?]
K161039	000

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b38f525a-33c0-4c2d-9d2b-6798d461cb15
Public Version Date: June 22, 2023
Public Version Number: 3
DI Record Publish Date: May 13, 2021