FDA UDI
In Commercial Distribution
🇺🇸 United States
HemaPrompt FG
DI: 00693501000152
·
Model: HPFG
·
AERSCHER, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- HemaPrompt FG
- Primary DI
- 00693501000152
- Version / Model
- HPFG
- Company Name
- AERSCHER, INC
- Labeler DUNS
- 926911454
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-08-05
- Public Version
- 4
- Public Version Date
- 2022-11-09
- Public Version Status
- Update
- Public Device Record Key
- 3ee0047f-f755-4c89-8735-eb6e5aa346b0
Device Description
HemaPrompt FG Fecal and Gastric Test Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- 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 |
|---|---|---|---|---|
| 54547 | Biological fluid occult blood screening IVD, kit, rapid colorimetric, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of biological fluids for the presence of occult blood within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. 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 |
|---|---|---|---|---|---|---|
| Primary | 00693501000152 | GS1 | ||||
| Unit of Use | 00069350100015 | GS1 |
Customer Contacts
- Phone
- 410-778-2957
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K972763 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 24 Degrees Celsius