FDA UDI
In Commercial Distribution
🇺🇸 United States
Henso
DI: 06970343581662
·
Model: PH Test Strips
·
Henso Medical (Hangzhou) Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Henso
- Primary DI
- 06970343581662
- Version / Model
- PH Test Strips
- Company Name
- Henso Medical (Hangzhou) Co., Ltd.
- Labeler DUNS
- 421316098
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-14
- Public Version
- 1
- Public Version Date
- 2023-02-22
- Public Version Status
- New
- Public Device Record Key
- 2b237d75-5df2-41f3-acff-5ce7afb0507f
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
- Yes
- 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 |
|---|---|---|---|---|
| LNW | Paper, Obstetric Ph | Clinical Chemistry | 862.1550 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62048 | Gastric pH strip | A paper strip impregnated with an indicator solution (e.g., universal indicator) intended to be used to measure the pH of gastric aspirate to verify the depth of placement of a nasogastric feeding tube. The strip changes colour when exposed to an acidic or basic solution. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06970343581662 | GS1 |