FDA UDI
In Commercial Distribution
🇺🇸 United States
Pointe Scientific, Inc. BS200 Wash Solution
DI: 00811727013446
·
Model: 12-BS200-SCS
·
POINTE SCIENTIFIC, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pointe Scientific, Inc. BS200 Wash Solution
- Primary DI
- 00811727013446
- Version / Model
- 12-BS200-SCS
- Company Name
- POINTE SCIENTIFIC, INC.
- Labeler DUNS
- 045623154
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- eb924d4e-e797-4fcf-a825-80548f6ca0cf
Device Description
Pointe Scientific, Inc. BS200 Wash Solution is packaged for use with the Mindray BS200 Chemical Analyzer and intended for cleaning after reagent testing. 9 x 40ml.
Device Characteristics
- Single Use
- No
- 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
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38773 | Medical device-decontamination agent | A non-sterile substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental, surgical instruments/devices, and/or laboratory analysers/instruments for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds (decontamination) prior to disinfection or sterilization. It includes a detergent and may be added, as manufacturer specified, to water for cleaning procedures and/or be applied directly to soiled devices immediately after use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811727013446 | GS1 |
Customer Contacts
- Phone
- 800-445-9853
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius