What is FDA product code PVT?

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.

Obstetrics & Gynecology › TherapeuticMaternity Kit

Dynacare HerCare Necessities Complete Kit

Name: Dynacare HerCare Necessities Complete Kit
Brand: Dynacare HerCare Necessities Complete Kit

Kit Contents: 2 Maxi Pads Super w/Wings 2 Maxi Pads Ultra Thin w/Wings 2 Feminine Hygiene Wipes

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Shandong (1), Fujian (1).

Chinese manufacturers registered for FDA product code PVT
Manufacturer	City	Province	Registered as	Device types
Hynaut Health Technology Co., Ltd.	Qingdao	Shandong	Contract manufacturer	68
Fujian Time AND Tianhe Industrial Co., Ltd.	Nanan	Fujian	Contract manufacturer	9

Record

Regulatory record for Dynacare HerCare Necessities Complete Kit
Listed by	Dynarex Corp., United States
FDA product code	PVT
Device type	Maternity Kit
Device class	Class 1
Regulation	21 CFR 884.5435
Establishment	Specification developer, Manufacturer
Premarket notification	Exempt
Record published	2026-05-29

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, manufacturing date
Packaging	Case of 50

Catalogue Numbers

Catalogue numbers for Dynacare HerCare Necessities Complete Kit
Catalogue number	Size	Status
1375		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Dynacare Necessities Complete Kit	Dynarex Corp.	1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.