Identity
- Trade Name
- Precision Systems 1500 mOsm Osmometry Standard FDA UDI
- Generic Name
- Osmolality IVD, calibrator FDA UDI
- Device Name
- Precision Systems 1500 mOsm Osmometry Standard, 125 mL bottle FDA UDI
- Model / Reference
- 2115 FDA UDI
- Description
- Precision Systems 1500 mOsm Osmometry Standard, 125 mL bottle FDA UDI
Identifiers
- Catalog Number
- 2115 FDA UDI
- Primary DI / UDI-DI
- 00850041049151 FDA UDI
- FDA Product Code
- JMZ FDA UDI
- GMDN Term
- Osmolality IVD, calibrator 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, calibrator
Precision Systems 1500 mOsm Osmometry Standard by Precision Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Osmolality IVD, calibrator.
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- Advanced Instruments 200 mOsm Calibration Standard - 2mL Ampule - Pkg 10 — Advanced Instruments, LLC · Class I
- Advanced Instruments Calibration Standard 2000 mOsm - 2mL Ampule - Pkg 10 — Advanced Instruments, LLC · Class I
- Advanced Instruments 500 mOsm Calibration Standard - 5mL Ampule - Pkg 10 — Advanced Instruments, LLC · Class I
- Advanced Instruments 400 mOsm Calibration Standard - 2mL Ampule - Pkg 10 — Advanced Instruments, LLC · Class I
- Advanced Instruments 1500 mOsm Calibration Standard - 5mL Ampule - Pkg 10 — Advanced Instruments, LLC · 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 507c5a01-33d1-4eed-8958-1c5ce6e3e6fd 36 fields · synced May 30, 2026