FDA UDI In Commercial Distribution 🇺🇸 United States

First Sign®

DI: 00841824101968 · Model: W454-FS · W.H.P.M. INC.
Product Codes
5
GMDN Terms
1
Identifiers
2
Pkg Device Count
25

Basic Information

Brand Name
First Sign®
Primary DI
00841824101968
Version / Model
W454-FS
Catalog Number
W454-FS
Company Name
W.H.P.M. INC.
Labeler DUNS
602085672
Distribution Status
In Commercial Distribution
Device Count in Pkg
25
Record Status
Published
Publish Date
2016-08-01
Public Version
4
Public Version Date
2022-06-10
Public Version Status
Update
Public Device Record Key
03fe6ac3-7349-469b-b80c-df17b0541a8e

Device Description

DOA 5 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/COC/mAMP/MOR/THC

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
Yes
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LAF Gas Chromatography, Methamphetamine
LDJ Enzyme Immunoassay, Cannabinoids
DKZ Enzyme Immunoassay, Amphetamine
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
DJG Enzyme Immunoassay, Opiates

GMDN Terms

Code Name
46994 Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Identifiers

Type ID
Primary 00841824101968
Unit of Use 00841824100374