Identity
- Trade Name
- Sapphire Suction Reservoir FDA UDI
- Generic Name
- Closed-wound/centesis drainage receptacle FDA UDI
- Device Name
- Sapphire Suction Reservoir FDA UDI
- Model / Reference
- 2001 Pouch FDA UDI
- Description
- Sapphire Suction Reservoir FDA UDI
Identifiers
- Catalog Number
- 2001 FDA UDI
- Primary DI / UDI-DI
- 00854373007070 FDA UDI
- 510(k) Number
- K905733 FDA UDI
- FDA Product Code
- GCY FDA UDI
- GMDN Term
- Closed-wound/centesis drainage receptacle FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4680 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 100 Milliliter FDA UDI
Category: Closed-wound/centesis drainage receptacle
Sapphire Suction Reservoir by Greer Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Closed-wound/centesis drainage receptacle.
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- One-Step™ — Merit Medical Systems, Inc. · Class I
- Thoracentesis and Paracentesis Set — Merit Medical Systems, Inc. · Class I
- One-Step™ — Merit Medical Systems, Inc. · Class I
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
Cleared under the same submission
K905733 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Greer Medical, Inc.
Sources (1)
- FDA UDI 6219c447-086e-46d7-b315-a3f5a8a9051b 38 fields · synced May 30, 2026