FDA.reportPublic FDA data

RADIOMETER AMERICA, INC.

Matched from indexed company URL: Radiometer America, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
15234561523456RADIOMETER AMERICA, INC.1Y2026-01-016836 Engle Rd Middleburg Heights OH US 44130
30104207363010420736Radiometer America, Inc1Y2026-01-01250 S Kraemer Blvd Brea CA US 92821

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860003561928safePICO - 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with gusset bottom, 1 safePICO 25Gx16mm (nsd)Arterial blood sampler with 25Gx16mm needle, with needle shield device (nsd) and vented TIPCAP, 1.5 mL.8007360600support@radiometeramerica.com
00860003561942VKR-5 - Kit of QC material for the validation of sensor linear response in ABL90, ABL80 COOX, ABL80 COOX OSM series8007360600support@radiometeramerica.com
00860003561959VKR-7 - Kit of QC material for the validation of sensor linear response in ABL800 series8007360600support@radiometeramerica.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
403761226340699K153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitJJY2016-01-28
403761634438308

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JJY12016-01-28

PMA#

PMN#

JUSTONE

1995-10-07

RADIOMETER AMERICA, INC.

EML 100

1994-04-26

RADIOMETER AMERICA, INC.

OXIMETER

1989-09-05

RADIOMETER AMERICA, INC.

50 records. Showing 1-40. Next

GUDID#