FDA UDI
In Commercial Distribution
🇺🇸 United States
EZ-Chek
DI: 00858293006175
·
Model: K100-0114
·
REPROCESSING PRODUCTS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- EZ-Chek
- Primary DI
- 00858293006175
- Version / Model
- K100-0114
- Catalog Number
- K100-0114
- Company Name
- REPROCESSING PRODUCTS CORPORATION
- Labeler DUNS
- 796083392
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-07
- Public Version
- 4
- Public Version Date
- 2019-08-16
- Public Version Status
- Update
- Public Device Record Key
- c11a0168-1385-4515-86b1-642ba81c1f23
Device Description
Blood Leak Test Strips
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FJD | Detector, Leak, Blood | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58093 | Haemodialysis treatment kit | A collection of sterile and disposable/consumable devices intended to be used to prepare for and perform a haemodialysis treatment with a haemodialysis system. It typically consists of tubing, haemodialysis dialysers, dialysate concentrates, and rinsing solutions for preparation of the extracorporeal circuit. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858293006175 | GS1 | ||||
| Package | 10858293006172 | GS1 | bag | 1 | In Commercial Distribution | |
| Package | 20858293006179 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 30858293006176 | GS1 | Carton | 22 | In Commercial Distribution | |
| Package | 40858293006173 | GS1 | Bag | 2 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123805 | 000 |