AccessGUDID - DEVICE: Baxter* Tip Cap ENFit® Syringe Compatible (00350770003108)

GUDID

Device Identifier (DI) Information

Brand Name: Baxter* Tip Cap ENFit® Syringe Compatible
Version or Model: H93853300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H93853300
Company Name: Avanos Medical, Inc.

Primary DI Number: 00350770003108
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 079375431 *Terms of Use

Device Description: H93853300 ENFit Bax Tip Cap Sterile White

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?
16617	Medicine bottle cap	A sturdy covering designed to close off and seal the top of a medicine bottle providing protection from the external environment. It will typically consist of a plastic cover that may include a glued or cemented liner/seal, e.g., rubber or plastic. Some devices are threaded for screwing on to the bottle. Medicine bottle caps are frequently made with a built-in safety feature locking mechanism making them child proof, e.g., require a push-down/screw action to open. This device is reusable until the contents of the bottle are exhausted.	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 [?]
K152857	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: b8d24c6a-c0b7-4062-9d2c-4c23648dcabe
Public Version Date: June 22, 2023
Public Version Number: 2
DI Record Publish Date: May 13, 2021