FDA UDI
In Commercial Distribution
🇺🇸 United States
Dako
DI: 05700571112182
·
Model: GC118
·
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Dako
- Primary DI
- 05700571112182
- Version / Model
- GC118
- Company Name
- AGILENT TECHNOLOGIES SINGAPORE PTE LTD
- Labeler DUNS
- 894671143
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-02
- Public Version
- 1
- Public Version Date
- 2025-09-10
- Public Version Status
- New
- Public Device Record Key
- 2a9b7d2b-e341-4bce-8560-cc28df093424
Device Description
Dako Omnis Waste Container 7 L
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| KPA | Slide stainer, automated | Pathology | 864.3800 | 1 |
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 | 05700571112182 | GS1 |
Customer Contacts
- Phone
- +1-800-227-9770
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 7 | Liter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius