AccessGUDID - DEVICE: Additive Port Cap (B21221011001)

GUDID

Device Identifier (DI) Information

Brand Name: Additive Port Cap
Version or Model: 21-01 100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 21-01 100
Company Name: INTERNATIONAL MEDICAL INDUSTRIES INC.

Primary DI Number: B21221011001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 053469565 *Terms of Use

Device Description: 100 Unit configuration of Additive Port Cap for B. Braun IV Bags

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):	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?
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: 308251e0-8448-4339-b404-6b553d1fbd49
Public Version Date: September 18, 2023
Public Version Number: 1
DI Record Publish Date: September 08, 2023