What is FDA product code MLS?

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

Obstetrics & Gynecology › SurgicalLabor And Delivery Kit

Regardo™

Name: Regardo™
Brand: Regardo™

Catalogue number LD00044O, listed by ROi CPS LLC, under Labor And Delivery Kit. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

9recalls on this code

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code MLS
Manufacturer	City	Province	Registered as	Device types
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71

Record

Regulatory record for Regardo™
Listed by	ROi CPS LLC
FDA product code	MLS
Device type	Labor And Delivery Kit
Device class	Class 2
Regulation	21 CFR 884.4530
Premarket notification	Exempt
Record published	2020-01-22
Record revised	2021-05-07 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Contains natural rubber latex
Label carries	lot or batch number, expiry date
Packaging	Pack of 3
Distribution end date	2021-05-07

Catalogue Numbers

Catalogue numbers for Regardo™
Catalogue number	Size	Status
LD00044O		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	3,909
Medline Industries, Inc.	Medline Industries, Inc.	3,405
ACS	American Contract Systems, Inc.	244
Centurion	Centurion Medical Products Corporation	159
Regard™	ROi CPS LLC	125
Regard™	Resource Optimization & Innovation, L.L.C.	63
Centurion Medical Products Corp	Medline Industries, Inc.	29
Aligned Medical Solutions	Aligned Medical Solutions	16
Medical Action Industries	Medical Action Industries, Inc.	11
Medline	Medline Industries, Inc.	6
Halyard	Avid Medical, Inc.	6
Devon	Cardinal Health	4

Showing 12 of 16. All products under Labor And Delivery Kit

Recalls

1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. 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
2024-12-26	Class I	Nonconforming Material/Component	There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends of the PIP and PEEP pre	414 kits
2023-03-22	Class II	Nonconforming Material/Component	The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.	70 kits
2022-03-18	Class II	Nonconforming Material/Component	A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.	1,501 convenience kits	2024-08-02
2021-11-04	Class II	Process control	The kit contains a non-sterile needle.	40 kits	2023-08-07
2021-08-10	Class II	Nonconforming Material/Component	Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.	12	2023-06-16
2021-06-14	Class II	Process design	Instructions for use updated to include the following cautionary statement for the heel warmer, “Activate away from the user’s face and away from the infant and others.”	688 units	2023-03-08
2021-06-14	Class II	Process design	Instructions for use updated to include the following cautionary statement for the heel warmer, “Activate away from the user’s face and away from the infant and others.”	608 units	2023-03-08
2021-06-14	Class II	Process design	Instructions for use updated to include the following cautionary statement for the heel warmer, “Activate away from the user’s face and away from the infant and others.”	976 units	2023-03-08
2020-10-12	Class II	Labeling Change Control	Labeling error, incorrect expiration date.	220 kits	2021-05-13

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.