What is FDA product code KYP?

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. 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.

First Aid Only · Snake Bite Suction Kit → General Hospital

Name: First Aid Only
Brand: First Aid Only

4manufacturers in China registered for this device type

2catalogue numbers in this listing

Who Else Makes It

Concentrated in Anhui (2), Shanghai (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code KYP
Manufacturer	City	Province	Registered as	Device types
Planet (Anhui) Medical Products Co., Ltd.	Chuzhou	Anhui	Contract manufacturer	30
Planet(Shanghai) International Co., Ltd.	Shanghai	Shanghai	Exporter	93
Planet (Anhui) International Co., Ltd.	Chuzhou	Anhui	Exporter	80
Guangzhou Nuoning Medical Supplies Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	62

Record

Regulatory record for First Aid Only
Listed by	Acme United Corp., United States
FDA product code	KYP
Device type	Snake Bite Suction Kit
Device class	Class 1
Regulation	21 CFR 880.5740
Establishment	Repacker / relabeller, Manufacturer
Premarket notification	Exempt
Record published	2022-01-05

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Over the counter	Yes
Supplied as a kit	Yes

Catalogue Numbers

Catalogue numbers for First Aid Only
Catalogue number	Size	Status
7103		In distribution
3027		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Radpad	Worldwide Innovations & Technologies, Inc.	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.

First Aid Only

Who Else Makes It

Record

Specifications

Catalogue Numbers

Same Product Code

Where China Actually Supplies