FDA UDI
In Commercial Distribution
🇺🇸 United States
Easy@Home Pregnancy Test Strip (40 tests kit)
DI: 00850253007840
·
Model: EZW1-S
·
EASY HEALTHCARE CORPORATION
Product Codes
0
GMDN Terms
1
Identifiers
4
Pkg Device Count
40
Basic Information
- Brand Name
- Easy@Home Pregnancy Test Strip (40 tests kit)
- Primary DI
- 00850253007840
- Version / Model
- EZW1-S
- Company Name
- EASY HEALTHCARE CORPORATION
- Labeler DUNS
- 080278407
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 40
- Record Status
- Published
- Publish Date
- 2016-12-23
- Public Version
- 5
- Public Version Date
- 2023-07-06
- Public Version Status
- Update
- Public Device Record Key
- fd444b71-5346-4778-aecc-99218f065c1a
Device Description
40 tests kit; HCG strips
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33819 | Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to aid detection of pregnancy, or as a predictor of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome). It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850253007847 | GS1 | Carton | 120 | In Commercial Distribution | |
| Primary | 00850253007840 | GS1 | ||||
| Unit of Use | 30850253007841 | GS1 | ||||
| Package | 20850253007844 | GS1 | Carton | 80 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K043443 | 000 |