FDA UDI
In Commercial Distribution
🇺🇸 United States
RightSpotpH®
DI: 00861145002607
·
Model: RSSB001
·
RIGHTBIO/METRICS INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- RightSpotpH®
- Primary DI
- 00861145002607
- Version / Model
- RSSB001
- Company Name
- RIGHTBIO/METRICS INC.
- Labeler DUNS
- 964861012
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-10
- Public Version
- 1
- Public Version Date
- 2018-12-11
- Public Version Status
- New
- Public Device Record Key
- 1560e996-55f1-41b4-b42a-1774f72968ab
Device Description
Small Bore Indicator
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| JLL | Tubeless Analysis, Gastric Acidity | Clinical Chemistry | 862.1320 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15164 | pH meter IVD | A manual, semi-automated, or automated instrument intended to be used for the qualitative and/or quantitative in vitro determination of the pH of a clinical specimen (i.e., its degree of acidity or alkalinity) by measuring hydrogen ion concentration. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40861145002605 | GS1 | Master Case | 350 | In Commercial Distribution | |
| Primary | 00861145002607 | GS1 | ||||
| Package | 20861145002601 | GS1 | Inner Carton | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 480-466-0041
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 125 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 52 Degrees Celsius