Affinity Bed Model 3600 Series
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Affinity EUDAMEDAffinity® 4 Birthing Bed FDA UDI
- Generic Name
- Birthing bed/table, powered FDA UDI
- Device Name
- Hospital Bed EUDAMEDFDA UDI
- Model / Reference
- P3700E EUDAMEDFDA UDI
- Description
- Hospital Bed FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887761000896 EUDAMEDFDA UDI
- Basic UDI-DI
- 0887761GMN000042U4 EUDAMED
- Direct Marketing DI
- 00887761000896 EUDAMED
- 510(k) Number
- K915779 FDA 510(k)
- FDA Product Code
- KNC FDA 510(k)FDA UDI
- EMDN Code
- V08060199 ELECTRIC MEDICAL BEDS - OTHER EUDAMED
- GMDN Term
- Birthing bed/table, powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 884.4900 FDA 510(k)
- Regulation Number
- 884.4900 FDA 510(k)FDA UDI
- Market of Registration
- France EUDAMED
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Affinity Bed Model 3600 Series is classified as an Obstetric Table (and Accessories) under the FDA’s nomenclature. This adjustable hospital bed is designed to support patients during obstetric procedures, offering specialized positioning and stability for maternal and fetal care. Its construction accommodates both labor and delivery settings, with features tailored to obstetrics and gynecology applications.
The device is supplied as a reusable, non-sterile medical bed with multiple model variants (P3600, P3601, 3605, P3606) and is regulated under FDA 510(k) clearance (K915779) and EU MDR compliance. It operates in clinical environments such as labor rooms, delivery suites, and recovery areas, with weight capacities and angle adjustments documented in manufacturer service manuals. Storage and maintenance follow manufacturer guidelines for reusable medical equipment.
Frequently asked questions
What clinical settings is the Affinity Bed Model 3600 Series intended for use in, and how does its design support obstetric procedures?
The Affinity Bed Model 3600 Series is designed specifically for obstetric care, making it suitable for labor rooms, delivery suites, and recovery areas. Its specialized features—such as adjustable positioning and enhanced stability—are tailored to support maternal and fetal care during labor and delivery procedures, ensuring optimal patient positioning for both the mother and baby.
Is the Affinity Bed Model 3600 Series reusable or single-use, and what does this mean for maintenance and cleaning?
The Affinity Bed Model 3600 Series is a reusable, non-sterile medical bed. This means it is intended for repeated use across multiple patients, requiring adherence to manufacturer guidelines for thorough cleaning, disinfection, and maintenance between uses to ensure hygiene and functionality.
What model variants are available in the Affinity Bed Model 3600 Series, and how might these differ in functionality?
The Affinity Bed Model 3600 Series includes multiple model variants: P3600, P3601, 3605, and P3606. While the exact functional differences between these models are detailed in the manufacturer’s service manuals, they likely vary in features such as weight capacity, angle adjustments, or additional positioning options tailored for specific obstetric or gynecological procedures.
How is the Affinity Bed Model 3600 Series regulated, and what does this mean for healthcare providers?
The Affinity Bed Model 3600 Series holds FDA 510(k) clearance (K915779) and complies with EU MDR regulations, indicating it meets established safety and performance standards for obstetric tables. This regulatory status assures healthcare providers that the device has undergone evaluation for its intended use in obstetrics and gynecology, though routine maintenance and adherence to manufacturer guidelines remain the responsibility of the facility.
What storage and handling instructions should be followed for the Affinity Bed Model 3600 Series to ensure longevity and proper function?
The Affinity Bed Model 3600 Series should be stored and handled according to the manufacturer’s guidelines for reusable medical equipment. This typically includes keeping the bed in a clean, dry environment, avoiding exposure to extreme temperatures or moisture, and following proper assembly and disassembly procedures to prevent wear and tear. Regular inspections for damage or wear are also recommended.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Affinity P3600, P3601, II Service Manual | Manualzz, PDF Hill-Rom Affinity and Affinity II Bed P3600 Service Manual.pdf - iFixit, AFFINITY BED MODEL 3600 SERIES (K915779) — FDA 510(k) | Innolitics
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K915779 | Class II | Active |
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Manufacturer
- Manufacturer
- Hill-Rom, Inc.
Sources (3)
- FDA 510(k) K915779 24 fields · synced Sep 18, 2026
- FDA UDI 14810530-6a89-48de-ac64-ead7205b3b93 34 fields · synced May 25, 2026
- EUDAMED 5d77eb58-569a-4411-acf8-454264415f4c 61 fields · synced Jul 12, 2026