Identity
- Trade Name
- PCA Lockbox 100 ml FDA UDI
- Generic Name
- Narcotics security storage cabinet FDA UDI
- Model / Reference
- 15061-131-0004 FDA UDI
Identifiers
- Catalog Number
- 15061-131-0004 FDA UDI
- Primary DI / UDI-DI
- 17290109153954 FDA UDI
- 510(k) Number
- K192860 FDA UDI
- FDA Product Code
- MRZ FDA UDI
- GMDN Term
- Narcotics security storage cabinet FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Narcotics security storage cabinet
PCA Lockbox 100 ml by Eitan Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Narcotics security storage cabinet.
- PCA Lockbox 500 ml — EITAN MEDICAL LTD · Class II
- PCA Lockbox 250 Strap and Pouch — EITAN MEDICAL LTD · Class II
- Sapphire PCA Lockbox 500mL Label — EITAN MEDICAL LTD · Class II
- PCA Lockbox 250mL — EITAN MEDICAL LTD · Class II
- Avoset AAP Cassette Lock US — EITAN MEDICAL LTD · Class II
Cleared under the same submission
K192860 also covers:
- AP 223-01 MICROBORE ADMINISTRATION SET WITH VENTED/NON-VENTED SPIKE, — EITAN MEDICAL LTD
- AP133-01- BLOOD SET WITH TWO NON-VENTED SPIKES, 2 ROLLER CLAMPS — EITAN MEDICAL LTD
- AP204-01- MICROBORE INFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSET — EITAN MEDICAL LTD
- AP206-01- INFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSETTE — EITAN MEDICAL LTD
- AP209-01 — EITAN MEDICAL LTD
- AP213-01-MICROBORE INFUSION SET WITH NON-VENTED SPIKE, SLIDE CLAMP, ADMINISTRATI — EITAN MEDICAL LTD
- AP214-01- MICROBORE YELLOW MARKED INFUSION SET WITH VENTED/NON-VENTED SPIK — EITAN MEDICAL LTD
- AP223-01- MICROBORE WITH NON-VENTED SPIKE, BACK CHECK VALVE, FILTER AND NEE — EITAN MEDICAL LTD
- AP240-01 MICROBORE INFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSETT — EITAN MEDICAL LTD
- AP240-01- MICROBORE INFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSET — EITAN MEDICAL LTD
- AP402-01 — EITAN MEDICAL LTD
- AP402-01 MICROBORE EPIDURAL YELLOW MARKED WITH VENTD_NON-VENTED SPIKE — EITAN MEDICAL LTD
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
- Eitan Medical Ltd
Sources (1)
- FDA UDI a49819b8-e007-400f-bf80-f4c174711b3c 36 fields · synced Jun 6, 2026