FDA UDI
In Commercial Distribution
🇺🇸 United States
HpFast
DI: 00893029002519
·
Model: GIS-22
·
GI Supply, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- HpFast
- Primary DI
- 00893029002519
- Version / Model
- GIS-22
- Catalog Number
- GIS-22
- Company Name
- GI Supply, Inc.
- Labeler DUNS
- 160990313
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-08
- Public Version
- 1
- Public Version Date
- 2021-07-16
- Public Version Status
- New
- Public Device Record Key
- 1bdc574b-d541-478e-b5f9-9cc34c5aabab
Device Description
HpFast detects the urease enzyme for the presumptive identification of Helicobacter pylori gastric mucosal biopsies. It is intended for in-vitro diagnostic use only.
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
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| LYR | Helicobacter Pylori | Microbiology | 866.3110 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51028 | Helicobacter pylori urease 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 detection of Helicobacter pylori bacteria urease enzyme in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00893029002519 | GS1 | ||||
| Package | 10893029002516 | GS1 | Master | 50 | In Commercial Distribution | |
| Package | 20893029002513 | GS1 | Dispenser | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 800-451-5797
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K944903 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius