Bed, Pediatric Open Hospital

Device Code: 2558

Product Code(s): FMS

Device Classification Information

• Device Type ID: 2558
• Device Name: Bed, Pediatric Open Hospital
• Regulation Description: Pediatric Medical Crib.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); General Hospital Devices Branch (GHDB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 880.5140 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: FMS
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 6-339 ASTM F1169-13
  Standard Consumer Safety Specification For Full-Size Baby Cribs
• 6-340 ASTM F2710-13
  Standard Consumer Safety Performance Specification For Commerical Cribs

Total Product Life Cycle

• Device Type ID: 2558
• Device: Bed, Pediatric Open Hospital
• Product Code: FMS
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Pediatric Medical Crib.
• CFR Regulation Number: 880.5140 [🔎]

Device Problems
Sticking	5
Mechanical Problem	3
Insufficient Information	3
Caster	3
Latch	2
Device Fell	2
Rail	2
Side Rail	2
Positioning Problem	2
Component Falling	1
Device Slipped	1
Device Operates Differently Than Expected	1
Adverse Event Without Identified Device Or Use Problem	1
Incorrect Measurement	1
Total Device Problems	29

TPLC Last Update: 2019-04-02 20:14:39