Identity
- Trade Name
- Precision Systems 800 mOsm Osmometry Standard FDA UDI
- Generic Name
- Osmolality IVD, control FDA UDI
- Device Name
- Precision Systems 800 mOsm Osmometry Standard, 250 mL bottle FDA UDI
- Model / Reference
- 2108 FDA UDI
- Description
- Precision Systems 800 mOsm Osmometry Standard, 250 mL bottle FDA UDI
Identifiers
- Catalog Number
- 2108 FDA UDI
- Primary DI / UDI-DI
- 00850041049083 FDA UDI
- FDA Product Code
- JMZ FDA UDI
- GMDN Term
- Osmolality IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Osmolality IVD, control
Precision Systems 800 mOsm Osmometry Standard by Precision Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Precision Systems 1200 mOsm Osmometry Standard, 250 mL bottle — PRECISION SYSTEMS, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Precision Systems, Inc.
Sources (1)
- FDA UDI d8cc01c2-eb3d-4ab9-8ded-7d4096bb5e7d 36 fields · synced May 30, 2026