AccessGUDID - DEVICE: Tamper Evident Cap with ENFit (B212572201001)

GUDID

Device Identifier (DI) Information

Brand Name: Tamper Evident Cap with ENFit
Version or Model: 57-220-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 57-220-100
Company Name: INTERNATIONAL MEDICAL INDUSTRIES INC.

Primary DI Number: B212572201001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 053469565 *Terms of Use

Device Description: Tamper Evident Cap for Use With ENFit® Syringes (ETEC)

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:	Yes
Prescription Use (Rx):	No
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?
65012	ENFit-formatted protective cap	A small, noninvasive, closed-ended, ENFit-formatted (ISO 80369-3) attachment intended to be attached to an enteral device (e.g., enteral syringe, feeding tube, administration set) with an ENFit connection to close the device lumen, typically to prevent fluid path contamination and/or spillage; it is not intended to disinfect/maintain disinfection. It is typically made of synthetic polymers and may incorporate a strap; it does not incorporate a filter or valve. 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 [?]
K170672	000

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: b35479a8-0ec6-4754-bda4-e7144f3307bc
Public Version Date: July 20, 2023
Public Version Number: 1
DI Record Publish Date: July 12, 2023