FDA UDI
In Commercial Distribution
🇺🇸 United States
Haemo-Diff®
DI: 04038917085830
·
Model: 14.1218
·
Sarstedt Aktiengesellschaft & Co.KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500
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Basic Information
- Brand Name
- Haemo-Diff®
- Primary DI
- 04038917085830
- Version / Model
- 14.1218
- Catalog Number
- 14.1218
- Company Name
- Sarstedt Aktiengesellschaft & Co.KG
- Labeler DUNS
- 388000270
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2025-09-25
- Public Version
- 1
- Public Version Date
- 2025-10-03
- Public Version Status
- New
- Public Device Record Key
- 56d69cfe-2f4c-49a8-8d03-cc5716230c37
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| JRC | MICRO PIPETTE | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63337 | Pipette tip IVD | 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 (e.g., reagent, buffer, biological specimen) is drawn for delivery to a target receptacle during an in vitro diagnostic procedure. It is typically used for manual procedures or onboard 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 04038917167918 | GS1 | ||||
| Primary | 04038917085830 | GS1 |
Customer Contacts
- Phone
- +1(800)257-5101
- [email protected]