FDA UDI
In Commercial Distribution
🇺🇸 United States
Iris
DI: 10837461002321
·
Model: 800-3215
·
BECKMAN COULTER IRELAND INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500
Basic Information
- Brand Name
- Iris
- Primary DI
- 10837461002321
- Version / Model
- 800-3215
- Catalog Number
- 800-3215
- Company Name
- BECKMAN COULTER IRELAND INC.
- Labeler DUNS
- 985071975
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2025-04-16
- Public Version
- 1
- Public Version Date
- 2025-04-24
- Public Version Status
- New
- Public Device Record Key
- d0bbff0d-9fb8-4a8c-ba17-f2fc847428b3
Device Description
The tubes are specimen receptacles for body fluids. The plastic test tubes are 12 mL and contain 500 per package.
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62225 | Assay container IVD, single-use | A reservoir (e.g., bottle, tube, cup) intended to be used to contain volumes of reagent, buffers, biological specimens, or other materials in preparation for in vitro diagnostic testing procedures performed in the laboratory. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10837461002321 | GS1 | ||||
| Unit of Use | 00837461002324 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 18 – 25 Degrees Celsius