Identity
- Trade Name
- APD Drain Manifold FDA UDI
- Generic Name
- Peritoneal dialysis system tubing set FDA UDI
- Device Name
- This set is designed to allow drainage of peritoneal dialysis effluent from the drain line on an automated peritoneal dialysis cycler tubing set into 2 drain bags. FDA UDI
- Model / Reference
- 5C4512 FDA UDI
- Description
- This set is designed to allow drainage of peritoneal dialysis effluent from the drain line on an automated peritoneal dialysis cycler tubing set into 2 drain bags. FDA UDI
Identifiers
- Catalog Number
- 5C4512 FDA UDI
- Primary DI / UDI-DI
- 00085412007755 FDA UDI
- 510(k) Number
- K791899 FDA UDI
- FDA Product Code
- KDJ FDA UDI
- GMDN Term
- Peritoneal dialysis system tubing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5630 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
Category: Peritoneal dialysis system tubing set
APD Drain Manifold by Baxter International Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K791899 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 II | Pending data |
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Manufacturer
- Manufacturer
- Baxter International Inc.
Sources (1)
- FDA UDI 2b3f41a4-588b-4721-8279-200f34db5907 37 fields · synced May 30, 2026