FDA UDI Not in Commercial Distribution 🇺🇸 United States

Accu-Clear

DI: 00633472601958 · Model: OVULATION TEST · PROCTER & GAMBLE MANUFACTURING COMPANY, THE
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50

Basic Information

Brand Name
Accu-Clear
Primary DI
00633472601958
Version / Model
OVULATION TEST
Company Name
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
Labeler DUNS
004238200
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
50
Record Status
Published
Publish Date
2020-11-11
Public Version
2
Public Version Date
2023-08-01
Public Version Status
Update
Public Device Record Key
77980562-15d6-4d1d-b4c2-b25c5b803479
Distribution End Date
2023-07-31

Device Description

AccuClear Ovul Strip 50ct US

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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
Yes
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
NGE Test, Luteinizing Hormone (Lh), Over The Counter

GMDN Terms

Code Name
60862 Natural conception assistance kit

Identifiers

Type ID
Package 10633472601955
Primary 00633472601958
Unit of Use 00633472000393

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 30 Degrees Celsius