MedtechSourcebook

316 CONTRACT MANUFACTURING LLC

Contract manufacturer ยท Indianapolis, IN

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
3038772438 (openFDA record; or search FDA's registration database)
FEI number
3038772438
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
316 Contract Manufacturing LLC (FDA owner/operator no. 10093596)
Registered address
11850 Brookville Rd, Suite 21, Indianapolis, IN 46239
Contract listings
1 device listings, 1 product codes, first listed Jun 10, 2025
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
BTMVentilator, Emergency, Manual (Resuscitator)Class IIAnesthesiologyContract manufacturingJun 10, 2025