AccessGUDID - DEVICE: Additive Port Cap (B2122101B1)

GUDID

Device Identifier (DI) Information

Brand Name: Additive Port Cap
Version or Model: 21-01B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 21-01B
Company Name: INTERNATIONAL MEDICAL INDUSTRIES INC.

Primary DI Number: B2122101B1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 053469565 *Terms of Use

Device Description: Tamper Evident Additive Port Cap for IV Bags - Fresenius Kabi, Non-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":	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?
63614	Luer-formatted protective cap	A small, noninvasive, closed-ended Luer attachment intended to be attached to a luminal device (e.g., catheter, intravenous administration or pressure-monitoring tubing, syringe) with a Luer 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
KPE	Container, I.V.

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: 581c404e-7ff8-4e1b-9268-ebf5e036421b
Public Version Date: July 20, 2023
Public Version Number: 1
DI Record Publish Date: July 12, 2023