FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Waste Container D512 REF 905-590
DI: 05700699055903
·
Model: 905-590
·
Radiometer Medical ApS
Product Codes
11
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Disposable Waste Container D512 REF 905-590
- Primary DI
- 05700699055903
- Version / Model
- 905-590
- Catalog Number
- 905-590
- Company Name
- Radiometer Medical ApS
- Labeler DUNS
- 308667539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-21
- Public Version
- 2
- Public Version Date
- 2023-09-05
- Public Version Status
- Update
- Public Device Record Key
- 1a108127-6f43-4fc7-baa2-0755b41913b6
Device Description
D512 Disposable waste container 600mL for ABL7XX
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
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CGA | GLUCOSE OXIDASE, GLUCOSE | Clinical Chemistry | 862.1345 | 2 |
| CGZ | ELECTRODE, ION-SPECIFIC, CHLORIDE | Clinical Chemistry | 862.1170 | 2 |
| CEM | ELECTRODE, ION SPECIFIC, POTASSIUM | Clinical Chemistry | 862.1600 | 2 |
| JFP | ELECTRODE, ION SPECIFIC, CALCIUM | Clinical Chemistry | 862.1145 | 2 |
| JGS | ELECTRODE, ION SPECIFIC, SODIUM | Clinical Chemistry | 862.1665 | 2 |
| KHP | ACID, LACTIC, ENZYMATIC METHOD | Clinical Chemistry | 862.1450 | 1 |
| CHL | Electrode measurement, blood-gases (pco2, po2) and blood ph | Clinical Chemistry | 862.1120 | 2 |
| JJS | Controls for blood-gases, (assayed and unassayed) | Clinical Chemistry | 862.1660 | 1 |
| MQM | BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM | Clinical Chemistry | 862.1113 | 1 |
| CIG | DIAZO COLORIMETRY, BILIRUBIN | Clinical Chemistry | 862.1110 | 2 |
| GKF | Instrument, hematocrit, automated | Hematology | 864.5600 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62172 | Laboratory waste receptacle IVD | A non-sterile container intended to collect and contain disposable materials/devices that have been contaminated due to contact with bodily fluids/substances (e.g., blood, sputum, urine, faeces) resulting from in vitro diagnostic procedures. It is typically in the form of a sack, box, or bottle made of durable plastic impervious to microorganisms. It may be used to collect solid and/or liquid waste from a laboratory instrument or analyser. This is a single-use device intended to be disposed of with its contents. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05700699055903 | GS1 |
Customer Contacts
- Phone
- +45999999999
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Warning biological hazard Single use