FDA UDI In Commercial Distribution 🇺🇸 United States

QUALITY CHOICE

DI: 00635515952249 · Model: 89-363 · CHAIN DRUG MARKETING ASSOCIATION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
QUALITY CHOICE
Primary DI
00635515952249
Version / Model
89-363
Catalog Number
QC-95224
Company Name
CHAIN DRUG MARKETING ASSOCIATION, INC.
Labeler DUNS
011920774
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-02-15
Public Version
3
Public Version Date
2018-07-06
Public Version Status
Update
Public Device Record Key
3120b370-af4d-4941-82ba-dcdf34e0f843

Device Description

Quality Choice 2 Second Flexible Tip Digital Thermometer

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
FLL Thermometer, Electronic, Clinical

GMDN Terms

Code Name
14035 Intermittent electronic patient thermometer

Identifiers

Type ID
Primary 00635515952249
Package 30635515952240
Package 10635515952246

Customer Contacts

Phone
866-326-1313

Premarket Submissions

Submission Number Supplement Number
K983887 000