AccessGUDID - DEVICE: Tamper Evident Cap (B2125725CE1)

GUDID

Device Identifier (DI) Information

Brand Name: Tamper Evident Cap
Version or Model: 57-25 CE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 57-25 CE
Company Name: INTERNATIONAL MEDICAL INDUSTRIES INC.

Primary DI Number: B2125725CE1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 053469565 *Terms of Use

Device Description: Blue Tamper Evident Luer Lock Caps for IV Syringes. Sterile, Tray of 10, box of 1000. Provides Evidence of Access and maintains sterility

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?
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
FMF	Syringe, Piston

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K861276	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: 99db35dd-a78c-48b0-8fd7-05db18b47e95
Public Version Date: September 30, 2022
Public Version Number: 4
DI Record Publish Date: September 23, 2016