What is FDA product code LRS?

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.

Regard™ · I.V. Start Kit → General Hospital

Name: Regard™
Brand: Regard™

7manufacturers in China registered for this device type

8catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (3), Hubei (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LRS
Manufacturer	City	Province	Registered as	Device types
Conod Medical Co., Limited	Changshu	Jiangsu	Contract manufacturer	48
Jiangsu NEW Pentastar Medical Products Co., Ltd.	Changzhou	Jiangsu	Exporter	146
Amsino Medical (Kunshan) Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	53
Hubei Lanbin Medical Group Co., Ltd.	Xiaogan	Hubei	Contract manufacturer	33
Zibo Qichuang Medical Products Co., Ltd.	Zibo	Shandong	Manufacturer	27
Yafho BIO-Technology Co., Ltd.	Guangzhou	Guangdong	Manufacturer	14
Xiamen ANK Hygiene Care Product Co., Ltd.	Xiamen	Fujian	Manufacturer	11

Record

Regulatory record for Regard™
Listed by	Resource Optimization & Innovation, L.L.C.
FDA product code	LRS
Device type	I.V. Start Kit
Device class	Class 2
Regulation	21 CFR 880.5200
Premarket notification	Exempt
Record published	2022-05-03
Record revised	2026-05-01 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Over the counter	Yes
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Packaging	Pack of 100
Distribution end date	2025-09-30

Catalogue Numbers

Catalogue numbers for Regard™
Catalogue number	Size	Status
405219REG		Withdrawn
382982		Withdrawn
405218REG		Withdrawn
303404		Withdrawn
303403		Withdrawn
361099		Withdrawn
361065		Withdrawn
361097		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	1,066
Centurion	Centurion Medical Products Corporation	886
Medline Industries, Inc.	Medline Industries, Inc.	740
Medline	Medline Industries, Inc.	621
Medical Action Industries	Medical Action Industries, Inc.	512
Curaplex	Bound Tree Medical, LLC	149
Motion Medical Distributing	Haslam Medical, Inc.	118
LSL Healthcare	Lsl Industries, Inc.	83
Vygon	Vygon Corp.	76
Trinity Sterile, Inc.	Trinity Sterile, Inc.	63
MediChoice	Owens & Minor Distribution, Inc.	46
McKesson	Mckesson Medical-Surgical Inc.	21

Showing 12 of 58. All products under I.V. Start Kit

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Regard™
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Resource Optimization & Innovation, LLC	UDI-DI	2022-02-28	Class II	Process control	A kit component, the PDI Prevantics Swab, was recalled.	3,570 kits	2022-05-24

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.

Regard™