Tamper Evident Cap

Basic Information

• Brand Name: Tamper Evident Cap
• Primary DI: B2125726STAQ1
• Version / Model: 57-26 STAQ
• Catalog Number: 57-26 STAQ; 57-302 W STAQ
• Company Name: INTERNATIONAL MEDICAL INDUSTRIES INC.
• Labeler DUNS: 053469565
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2025-03-04
• Public Version: 3
• Public Version Date: 2026-04-20
• Public Version Status: Update
• Public Device Record Key: a81dad00-870d-49c4-99da-69cb19cfec58

Device Description

Tamper Evident Cap - STAQ Logo, Tray of 10 Product is available in multiple shipping configurations: - 57-26 STAQ = 100 primary packages per box (1000 devices) - 57-302 W STAQ = 21 primary packages per pouch, 7 pouches per box (1470 devices total)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMF	Syringe, Piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	B2125726STAQ0	HIBCC
Primary	B2125726STAQ1	HIBCC
Package	B21257302WSTAQ2	HIBCC	Tyvek Pouch	21	In Commercial Distribution
Package	B21257302WSTAQ3	HIBCC	Box	7	In Commercial Distribution
Package	B2125726STAQ2	HIBCC	Box	100	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K231095	000