Nuby

19 catalogue numbers from 81177, listed by LUV N' Care, Ltd., United States, under Ring, Teething, Fluid-Filled. 18 manufacturers in China are registered for this product code.

Registry build 21.09.26
18manufacturers in China registered for this device type
19catalogue numbers in this listing
1510(k) clearance
1recall

Who Else Makes It

Concentrated in Guangdong (11), Zhejiang (2), Hebei (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KKO
Manufacturer City Province Registered as Device types
Essentia Industries Ltd. Dong Guan Guangdong Contract manufacturer 31
Foshan City Shunde Jiajun Plastic & Hardware Products Co Ltd Foshan Guangdong Contract manufacturer 11
Huizhou Xinghuayuan Houseware Co., Ltd. Huizhou Guangdong Contract manufacturer 3
He Gao Plastic Factory Shantou Guangdong Contract manufacturer 2
Treasure Baby Toys (Dongguan) Limited Dongguan Guangdong Contract manufacturer 1
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Ningbo Raffini Import & Export Co., Ltd. Ningbo Zhejiang Manufacturer 19
Gavin Biotechnology Co., Ltd. Jinzhong Shanxi Manufacturer 16
Elung Industrial Co., Ltd. T.S.T.,Kowloon Hong Kong Exporter 14
Hubei Xinyunqi Household Products Co., Ltd. Tongshan Hubei Manufacturer 11
Solid Toys IND. Ltd. Boluo County, Huizhou,City Guangdong Contract manufacturer 8
Dongguan Qing Xi Essentia Industries Ltd Dongguan Guangdong Manufacturer 8

Showing 12 of 18. All 18 manufacturers in China registered for Ring, Teething, Fluid-Filled

Record

Regulatory record for Nuby
Listed by LUV N’ Care, Ltd., United States
FDA product code KKO
Device type Ring, Teething, Fluid-Filled
Device class Class 2
Regulation 21 CFR 872.5550
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2025-01-07
Record revised 2018-03-29 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries lot or batch number, manufacturing date
Packaging Pack of 4, pack of 12, pack of 6, pack of 2, blister of 2

Catalogue Numbers

Catalogue numbers for Nuby
Catalogue number Size Per pack Status
81177 In distribution
633 2 In distribution
6648 In distribution
602 In distribution
600 In distribution
625 In distribution
671 3 In distribution
6921 In distribution
601 In distribution
6909 In distribution
49196 In distribution
509 2 In distribution
567 In distribution
621 In distribution
6938 In distribution
6884 In distribution
624 In distribution
6937 In distribution
92419 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Green Sprouts O2cool, LLC 13
Sassy Sassy Baby, Inc 11
Bright Starts Kids II, Inc. 10
Dr. Brown’s Dr. Brown’s Company 7
Baby Einstein Kids II, Inc. 6
MAM Mam USA Corporation 6
Momcozy Shenzhen Lutejiacheng Supply Chain Management Co., Ltd. 2
Sesame Beginnings Regent Baby Products Corp. 2
Ingenuity Kids II, Inc. 2
Lamaze Tomy International 2
Fun Ice Ring Teether- 2pk Munchkin Inc. 1
Always My Baby LUV N’ Care, Ltd. 1

Showing 12 of 25. All products under Ring, Teething, Fluid-Filled

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K092494 2010-03-01

Recalls

The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated FDA class Root cause Reason Quantity Closed
2009-07-17 Not classified PMA Gel filled teethers were found to contain to contain Bacillus circulans and Bacillus subtilis. 546,320 units 2013-02-28

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer