Who else makes this device?

Name: Mark III MIL Resuscitatorwith butyl rubber outer cover and Mark III pa
Brand: Mark III MIL Resuscitatorwith butyl rubber outer cover and Mark III pa

Anesthesiology › TherapeuticVentilator, Emergency, Manual (Resuscitator)

Mark III MIL Resuscitatorwith Butyl Rubber Outer Cover and Mark III Pa

Ambu Mark III (Mil) resuscitator with butyl outer cover, complete with Ambu Mark III patient valve, transparent face mask size 5, special hanging strap with snap hook and gas filter adapter…

Registry build 21.09.26

Ambu Mark III (Mil) resuscitator with butyl outer cover, complete with Ambu Mark III patient valve, transparent face mask size 5, special hanging strap with snap hook and gas filter adapter (filter thread 2.342in x 8 threads/in.), supplied in pouch & carton

8manufacturers in China registered for this device type

4catalogue numbers in this listing

4510(k) clearances naming this product code

Who Else Makes It

Concentrated in Fujian (4), Zhejiang (1), Guangdong (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 BTM
Manufacturer	City	Province	Registered as	Device types
Flexicare Medical (Dongguan) Ltd.	Dongguan	Guangdong	Contract manufacturer	48
GaleMed (Xiamen) Co., Ltd.	Xiamen	Fujian	Contract manufacturer	33
Polymed (Xiamen) Plastic Industrial Co., Ltd.	Xiamen	Fujian	Contract manufacturer	17
VR Medical Technology Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	13
Ambu Limited	Xiang Yu F.T.Z., Xiamen	Fujian	Contract manufacturer	11
Huzhou Junda Industry Co., Ltd.	Anji	Zhejiang	Contract manufacturer	129
Laerdal Medical (Suzhou) Co., Ltd.	215009 Suzhou Jiangsu Province		Repacker / relabeller	12
Xiamen Compower Medical Tech. Co., Ltd.	Xiamen	Fujian	Contract manufacturer	9

Record

Regulatory record for Mark III MIL Resuscitatorwith butyl rubber outer cover and Mark III pa
Listed by	Ambu A/S, Denmark
FDA product code	BTM
Device type	Ventilator, Emergency, Manual (Resuscitator)
Device class	Class 2
Regulation	21 CFR 868.5915
Establishment	Specification developer, Private-label distributor, Manufacturer, Exporter
Record published	2016-12-19
Record revised	2026-01-30 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number
Storage	Handling environment temperature -20 to 50 °C; Storage environment temperature -40 to 70 °C
Packaging	Pack of 6
Distribution end date	2018-03-09

Catalogue Numbers

Catalogue numbers for Mark III MIL Resuscitatorwith butyl rubber outer cover and Mark III pa
Catalogue number	Size	Status
A233003000		In distribution
A233004000		In distribution
A233004000I		In distribution
A233006000		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Ventlab	Ventlab, LLC	405
CPR-2 Bag	Mercury Medical Enterprises, LLC	231
CPR Bag	Mercury Medical Enterprises, LLC	187
Vital Signs™	Airlife, Inc.	102
Medline	Medline Industries, Inc.	78
Spur® II Pediatric ResuscitatorSingle Patient Use Resuscitator	Ambu A/S	74
Spur® II Adult ResuscitatorSingle Patient Use Resuscitator	Ambu A/S	66
Hudson RCI	Teleflex Medical LLC	56
Medline Industries, Inc.	Medline Industries, Inc.	53
Portex	ICU Medical, Inc	45
Spur® II Infant ResuscitatorSingle Patient Use Resuscitator	Ambu A/S	45
Curaplex®	Bound Tree Medical, LLC	38

Showing 12 of 342. All products under Ventilator, Emergency, Manual (Resuscitator)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K152931	2016-08-29
K102824	2011-01-28
K053140	2005-12-23
K053142	2005-12-20

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.