AccessGUDID - DEVICE: ENFit Pharm Cap (00350770000435)

GUDID

Device Identifier (DI) Information

Brand Name: ENFit Pharm Cap
Version or Model: PC-ENC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PC-ENC
Company Name: Avanos Medical, Inc.

Primary DI Number: 00350770000435
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 079375431 *Terms of Use

Device Description: ENFit Pharm Cap Size E NonSterile Purp

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):	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?
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
KYX	DISPENSER, LIQUID MEDICATION

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ed5e1418-0a44-4b54-b079-d04d87ab252e
Public Version Date: June 22, 2023
Public Version Number: 2
DI Record Publish Date: April 29, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10350770000432	16	00350770000435		In Commercial Distribution	CS

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 20350770000439 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(844)428-2667
Email: PIQ@AVANOS.COM

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES