Maternity Kit
The Maternity Kit is an obstetrics/gynecology convenience kit containing supplies and accessories used during the labor, delivery, and immediate postpartum period to support patient care in a maternity setting. Product code PVT is established as a convenience kit under FDA's 1997 Convenience Kits Interim Regulatory Guidance and is under enforcement discretion, not requiring a 510(k) if all guidance criteria are met. It is classified as FDA Class I under regulation 21 CFR 884.5435, subject only to general controls. It falls under the Obstetrics/Gynecology medical specialty and is not flagged as an implant or life-sustaining device.
Basic Information
- Product Code
- PVT
- Device Class
- FDA class 1
- Regulation Number
- 884.5435
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 7
Device Characteristics
Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.