FDA UDI
In Commercial Distribution
🇺🇸 United States
InSure® ONE™
DI: 00850093003323
·
Model: 01
·
ENTERIX INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- InSure® ONE™
- Primary DI
- 00850093003323
- Version / Model
- 01
- Company Name
- ENTERIX INC.
- Labeler DUNS
- 002224009
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-05
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- e4961a21-93c7-4e98-82d2-c305ae2d5e68
Device Description
InSure® ONE™ Test Strip: Sold in Vials of 25 Strips (Part Number 12045.01) or in a sealed, bulk pouch of 200 Strips (Part Number 12041.01)
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KHE | Reagent, Occult Blood | Hematology | 864.6550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54533 | Faecal occult blood IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00850093003347 | GS1 | Pouch | 200 | In Commercial Distribution | |
| Primary | 00850093003323 | GS1 | ||||
| Package | 00850093003330 | GS1 | Vial | 25 | In Commercial Distribution |
Customer Contacts
- Phone
- 18005313681
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170548 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 77 Degrees Fahrenheit