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

Medline · Labor and Delivery Kit → Obstetrics & Gynecology

Name: Medline
Brand: Medline

1manufacturer

6catalogue numbers in this listing

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 Medline
Listed by	Medline Industries, Inc., United States
FDA product code	MLS
Device type	Labor And Delivery Kit
Device class	Class 2
Regulation	21 CFR 884.4530
Premarket notification	Exempt
Record published	2020-05-18
Record revised	2022-06-17 (version 2)

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	Labelled latex-free
Label carries	lot or batch number, expiry date
Packaging	Case of 20, case of 12
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Medline
Catalogue number	Size	Status
DYNDL1550		In distribution
CDS982908I		In distribution
DYNJ01105C		In distribution
M101425		In distribution
DYNDV2113		In distribution
CDS982907K		In distribution

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
Halyard	Avid Medical, Inc.	6
Devon	Cardinal Health	4
Instrapac	Robinson Healthcare Limited	4

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

Recalls Naming This Product

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

Recalls naming the identifiers of Medline
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Medline Industries, LP – Northfield	UDI-DI	2023-11-15	Class I	Nonconforming Material/Component	Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse As	228 units

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.

Medline