Spectrum SM109

by Dhanirama LLC GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00844064049335 UDI-DI	Date10 May 2019Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name: Spectrum
Generic Name: Aneroid manual sphygmomanometer
Model / Reference: SM109

Primary DI / UDI-DI: 00844064049335
510(k) Number: K090014
FDA Product Code: DXN
GMDN Term: Aneroid manual sphygmomanometer

Device Class: Class II
Regulation Number: 870.1130
GUDID distribution status: In Commercial Distribution

Other devices from Dhanirama LLC

Spectrum SM109

Class II

Properties

Contains Latex
Prescription Use
Over-the-Counter
Lot / Batch Number
Manufacturing Date

Other properties (9)

Sterile: No
Single Use: No
Implantable: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No