FDA UDI
In Commercial Distribution
🇺🇸 United States
m2000
DI: 20884999046447
·
Model: 04J71-17
·
ABBOTT MOLECULAR INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
96
Basic Information
- Brand Name
- m2000
- Primary DI
- 20884999046447
- Version / Model
- 04J71-17
- Catalog Number
- 04J71-17
- Company Name
- ABBOTT MOLECULAR INC.
- Labeler DUNS
- 878263359
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 96
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 4
- Public Version Date
- 2023-09-29
- Public Version Status
- Update
- Public Device Record Key
- e71aed10-c6f2-4eb0-9d22-c73fd93abcf9
Device Description
200ul Pipette Tips
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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| JJH | CLINICAL SAMPLE CONCENTRATOR | Clinical Chemistry | 862.2310 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16822 | Pipette tip | A device formed as a pointed cylindrical tip that is attached to the dispensing opening of a pipette or a dispenser and where the required volume of liquid is drawn for delivery to the target receptacle. It may show a gradient scale or not and is usually made of plastic but may also be made of glass. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20884999046447 | GS1 | ||||
| Unit of Use | 00884999046443 | GS1 | ||||
| Package | 30884999046444 | GS1 | CASE | 24 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)553-7042
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092705 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity