Identity
- Trade Name
- Custom Healthcare Systems, Inc. FDA UDI
- Generic Name
- Lumbar puncture kit FDA UDI
- Model / Reference
- CUS1365-02 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811870035166 FDA UDI
- FDA Product Code
- OGJ FDA UDI
- GMDN Term
- Lumbar puncture kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5140 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Lumbar puncture kit
Custom Healthcare Systems, Inc. by Manus Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lumbar puncture kit.
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- Curity — Cardinalhealth · Class II
- CARDINAL HEALTH — Cardinal Health 200, 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Manus Medical, LLC
Sources (1)
- FDA UDI e85396f8-8b42-400e-9afd-b5416aa5f3bb 32 fields · synced Jun 8, 2026