Pointe Scientific, Inc.
- Primary DI
- 00811727013002
- Brand
- Pointe Scientific, Inc.
- Company
- POINTE SCIENTIFIC, INC.
- Model
- HD990-840
- Catalog number
- HD990-840
- Device description
- Hitachi 917 Detergent. 12 x 70 ml.
- Published
- 2016-08-31
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- false
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00811727013002 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00811727013002 | 00811727013002 | 811727013002 | 0811727013002 |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 15 Degrees Celsius | 30 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 045623154
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00811727015709 | Pointe Alkaline Phosphatase on the BS480 | 14-A7516-225 | 14-A7516-225 | 2020-05-28 |
| 00811727015723 | Pointe Amylase on BS480 Analyzer | 14-A7564-120 | 14-A7564-120 | 2020-05-28 |
| 00811727015730 | Pointe AST on the BS480 Analyzer | 14-A7561-375 | 14-A7561-375 | 2020-05-28 |
| 00811727015754 | Pointe Calcium Arsenazo for BS480 | 14-C7529-360 | 14-C7529-360 | 2020-05-28 |
| 00811727015778 | Pointe Cholesterol on BS480 | 14-C7510-480 | 14-C7510-480 | 2020-05-28 |
| 00811727015792 | Pointe Carbon Dioxide on the BS480 | 14-C7502-160 | 14-C7502-160 | 2020-05-28 |
| 00811727015839 | Pointe GGT on BS480 | 14-G7571-200 | 14-G7571-200 | 2020-05-28 |
| 00811727015846 | Pointe Glucose Hexokinase for BS480 | 14-G7517-480 | 14-G7517-480 | 2020-05-28 |
| 00811727015860 | Pointe autoHDL for the BS480 | 14-H7545-300 | 14-H7545-400 | 2020-05-28 |
| 00811727015877 | Pointe Homocysteine for BS480 | 14-H7575-144 | 14-H7575-144 | 2020-05-28 |
| 00811727015884 | Pointe Total Iron for the BS480 | 14-HI904-350 | 14-HI904-350 | 2020-05-28 |
| 00811727015693 | Pointe Albumin on BS480 Analyzer | 14-A7502-480 | 14-A7502-480 | 2020-05-28 |
| 00811727018632 | Pointe Scientific CK-MB | C7563-30 | C7563-30 | 2021-02-28 |
| 00811727018649 | Pointe Scientific CK-MB | C7563-90 | C7563-90 | 2021-02-28 |
| 00811727014139 | Pointe G6PD Reagent | G7583-180 | G7583-180 | 2021-01-30 |
| 00811727015594 | Pointe Lipoprotein (a) Control Set | L7597-CTL | L7597-CTL | 2021-01-30 |
| 00811727015679 | Pointe G6PD Controls | G7583-CTL | G7583-CTL | 2021-01-30 |
| 00811727015815 | Pointe CRP Reagent | 14-C7568-480 | 14-C7568-480 | 2021-01-30 |
| 00811727015891 | Pointe Lactate Reagent | 14-L7596-380 | 14-L7596-380 | 2021-01-30 |
| 00811727015907 | Pointe Lactate Dehydrogenase Reagent | 14-L7572-200 | 14-L7572-200 | 2021-01-30 |
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