Vacuette

VACUETTE® TUBE 9 ml Z Urine No Additive 16x100 yellow cap-yellow ring, Conical Base, non-ridged

Registry build 21.09.26
79manufacturers in China registered for this device type
19catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (29), Zhejiang (24), Guangdong (8). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FMH
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Amsino Medical (Kunshan) Co., Ltd. Kunshan Jiangsu Contract manufacturer 53
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Allmed Medical Products Co., Ltd. Zhijiang Hubei Contract manufacturer 43
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Jiangsu JianYu Health Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 35
Primecare Medical (Suzhou) Co., Ltd. Changshu Jiangsu Contract manufacturer 20
Shanghai Huayue Packaging Products Co., Ltd. Fengxian District Shanghai Contract manufacturer 18
Meifu Medical Technology Suzhou Co., Ltd. Suzhou Jiangsu Contract manufacturer 13
Ningbo Mflab Medical Instruments Co., Ltd. Ningbo Zhejiang Contract manufacturer 11

Showing 12 of 79. All 79 manufacturers in China registered for Container, Specimen, Sterile

Record

Regulatory record for Vacuette
Listed by Greiner BIO-ONE Gmbh, Austria
FDA product code FMH
Device type Container, Specimen, Sterile
Device class Class 1
Regulation 21 CFR 864.3250
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
Premarket notification Exempt
Record published 2020-09-24
Record revised 2021-08-06 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Contains natural rubber latex
Label carries lot or batch number, expiry date
Storage Storage environment temperature 4 to 25 °C
Packaging Pack of 24, pack of 300, pack of 100, pack of 200, pack of 400, pack of 10
Distribution end date 2021-12-03

Catalogue Numbers

Catalogue numbers for Vacuette
Catalogue number Size Per pack Status
455007 50 In distribution
724320 In distribution
455023 50 In distribution
455028 50 In distribution
724310 In distribution
450253V1 In distribution
455024 50 In distribution
456065 50 In distribution
455227 50 In distribution
724325 In distribution
450218 In distribution
450225 In distribution
455029 50 In distribution
456008 50 In distribution
456007 50 In distribution
724321 In distribution
455210 50 In distribution
455209 50 Withdrawn
724300 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medline Industries, Inc. Medline Industries, Inc. 103
Corning® Corning Incorporated 49
Cardinal Health Cardinal Health 200, LLC 42
Medline Medline Industries, Inc. 41
Bioseal Inc. Bioseal 37
Centurion Centurion Medical Products Corporation 29
Globe Scientific Globe Scientific, LLC 29
Avaline Medical NJ LLC Avaline Medical NJ Limited Liability Company 27
Sterile Specimen Container Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V. 20
Precision Cardinal Health 15
Dover Cardinal Health 14
Samco Clicktainer Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V. 14

Showing 12 of 182. All products under Container, Specimen, Sterile

Recalls Naming This Product

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

Recalls naming the identifiers of Vacuette
Recalled by Identified by Initiated FDA class Root cause Reason Quantity Closed
C.A. Greiner & Sohne Gesellschaftmbh UDI-DI 2020-04-03 Class II Under Investigation by firm While transferring blood the needle may dislodged and remain in the tube stopper which may cause needle stick injury or blood leakage. 90,400 pieces. 2021-07-25

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