Identity
- Trade Name
- PCA Lockbox 100 mL FDA UDI
- Generic Name
- Medicine cabinet FDA UDI
- Model / Reference
- 15061-131-0004 FDA UDI
Identifiers
- Catalog Number
- 15061-131-0004 FDA UDI
- Primary DI / UDI-DI
- 17290109150021 FDA UDI
- 510(k) Number
- K123049 FDA UDI
- FDA Product Code
- MRZ FDA UDI
- GMDN Term
- Medicine 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: Medicine 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 Medicine cabinet.
- Perfusor® — B. BRAUN MEDICAL INC. · Class II
- PCA Lockbox 250mL — EITAN MEDICAL LTD · Class II
Cleared under the same submission
K123049 also covers:
- AP133-01 - BLOOD SET WITH 2 NON-VENTED SPIKES, 200 FILTER AND NEEDLESS Y-SITE — EITAN MEDICAL LTD
- AP133-01 BLOOD SET WITH 2 NON-VENTED SPIKES, 200μ FILTER AND NEEDLELESS Y- — EITAN MEDICAL LTD
- AP204 MICROBORE WITH NON-VENTED SPIKE, 0.2 FILTER AND BACK CHECK VALVE — EITAN MEDICAL LTD
- AP210-01 MICROBORE WITH NON-VENTED SPIKE AND 1.2μ FILTER — EITAN MEDICAL LTD
- AP231-01 - INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHECK VALVE, 2 — EITAN MEDICAL LTD
- AP232-01 - MICROBORE INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHEC — EITAN MEDICAL LTD
- AP233-01 - INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, 1.2µ FILTER, NEEDLE — EITAN MEDICAL LTD
- AP240-01 MICROBORE WITH NON-VENTED SPIKE, 1.2 FILTER AND BACK CHECK VALVE — EITAN MEDICAL LTD
- AP331-01 - NON PVC UV RESISTANT MICROBORE WITH VENTED/NON-VENTED SPIKE — EITAN MEDICAL LTD
- AP410-01 - SECONDARY INFUSION SET WITH VENTED/NONVENTED DRIP CHAMBER — EITAN MEDICAL LTD
- AP431-01 INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHECK VALVE, — EITAN MEDICAL LTD
- AP432-01 INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHECK VALVE, — 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 b112187b-24cc-4df0-aa46-8aecf37c0068 36 fields · synced Jun 7, 2026