Identity
- Trade Name
- High Pressure Luer Lock Set, Single Lumen 300mmHg FDA UDI
- Generic Name
- Hysteroscopic irrigation/insufflation system FDA UDI
- Model / Reference
- HLL003 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860936000341 FDA UDI
- FDA Product Code
- HRX FDA UDILGZ FDA UDIHIG FDA UDI
- GMDN Term
- Hysteroscopic irrigation/insufflation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 FDA UDI880.5725 FDA UDI884.1700 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Pressure — 400 millibar FDA UDI
High Pressure Luer Lock Set, Single Lumen 300mmHg by Thermedx, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Thermedx, LLC
Sources (1)
- FDA UDI 1ff34655-34a0-4e50-b4cc-06148d5006c3 34 fields · synced May 30, 2026