FDA UDI
In Commercial Distribution
🇺🇸 United States
InSure® ONE™
DI: 00850093003316
·
Model: 01
·
ENTERIX INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- InSure® ONE™
- Primary DI
- 00850093003316
- 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
- 8
- Public Version Date
- 2022-04-08
- Public Version Status
- Update
- Public Device Record Key
- 7c369247-d45a-4ba2-880e-d021c15d4ddc
Device Description
InSure® ONE™ Collection Kit: Available in 10-packs (Part Numbers 15022.01, 15027.01, 15240.01, and 90010.01), 25-packs (Part Number 90025.01) and 50-packs (15030.01, 15040.01, and 90050.01)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KHE | Reagent, Occult Blood | Hematology | 864.6550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61352 | Faecal specimen collection kit IVD, home-use | A collection of devices and materials intended to be used by a layperson in the home to self-collect a faecal (stool) sample for subsequent in vitro diagnostic testing or screening purposes (e.g., occult blood, cytology) in a clinical laboratory. The kit may consist of a specimen container(s) with or without an additive/medium (e.g., cell or nucleic acid preservative solution, Carey-Blair transport medium), collection assistive device(s) (e.g., blush, spatula), gloves, labels, and/or a return packing/envelope for submission/mailing to the clinical laboratory. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30850093003317 | GS1 | Case | 50 | In Commercial Distribution | |
| Primary | 00850093003316 | GS1 | ||||
| Package | 20850093003310 | GS1 | Case | 25 | In Commercial Distribution | |
| Package | 10850093003313 | GS1 | Case | 10 | 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 – 37 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from Heat and Direct Sun Light
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 99 Degrees Fahrenheit