PC

LITHOLYME,JERRYCAN,5L,2/CS RUS

Registry build 21.09.26
4manufacturers in China registered for this device type
18catalogue numbers in this listing
1recall

Who Else Makes It

Concentrated in Zhejiang (2), Shandong (1), Guangdong (1).

Chinese manufacturers registered for FDA product code CBL
Manufacturer City Province Registered as Device types
Zhejiang Haisheng Medical Device Co., Ltd. Shaoxing Zhejiang Contract manufacturer 21
Shandong Jinlai Huanhai Medical Technology Co., Ltd. Yantai Shandong Manufacturer 19
Excellentcare Medical (Huizhou) Ltd. Huizhou Guangdong Manufacturer 14
Jianshi Biotechnology (Zhejiang) Co., Ltd. Yuyao Zhejiang Manufacturer 6

Record

Regulatory record for PC
Listed by Allied Medical LLC, United States
FDA product code CBL
Device type Absorbent, Carbon-Dioxide
Device class Class 1
Regulation 21 CFR 868.5300
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2023-12-11
Record revised 2025-10-13 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number, expiry date, manufacturing date
Packaging Pack of 12, pack of 6, pack of 2, pack of 10, case of 6, case of 2

Catalogue Numbers

Catalogue numbers for PC
Catalogue number Size Status
55-01-0015 In distribution
55-01-0017 In distribution
55-01-0013-RU In distribution
55-01-0041 In distribution
55-01-0023 In distribution
55-01-0027 In distribution
55-01-0014-RU In distribution
55-01-0029 In distribution
55-01-0028 In distribution
55-01-0013 In distribution
55-01-0026 In distribution
55-01-0019 In distribution
55-01-0014 In distribution
55-01-0016 In distribution
55-01-0018 In distribution
55-01-0014-KZ In distribution
55-01-0025 In distribution
55-01-0013-KZ In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Atrasorb Atrasorb Industria DE Produtos Hospitalares Ltda 45
Amsorb® Plus Armstrong Medical Ltd. 13
Medisorb™ AirLife Finland Oy 11
Sofnolime® Molecular Products Ltd 5
Sodasorb® Molecular Products Ltd 4
SpiraLith Ca Micropore Inc 4
Xenon Master Medi Nuclear Corp., Inc. 3
Absorbent, Carbon-Dioxide Medi Nuclear Corp., Inc. 2
Medline Medline Industries, Inc. 2
Sodasorb® Hmed, 4-8, W-V Indicating, Canister Pak (12 bags/box) Molecular Products Ltd 2
Sodasorb® Hmed, 4-8, W-V Indicating, Individual Canister Pak, U-RAE Molecular Products Ltd 2
Sodasorb® Hmed, 4-8, W-V Indicating, Individual Canister Pak Molecular Products US Holdings, Inc. 2

Showing 12 of 31. All products under Absorbent, Carbon-Dioxide

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
2010-08-12 Not classified Other The granules do not absorb as long as expected in the anesthesia machines 949 pails, 335/12-canister cases, and 706/12-refill bag case 2012-03-28

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