Anesthesiology › DiagnosticSpirometer, Diagnostic

Polytech Filter

Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for single patient use only.

Registry build 21.09.26
10manufacturers in China registered for this device type
190catalogue numbers in this listing
1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (5), Guangdong (3), Fujian (1). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code BZG
Manufacturer City Province Registered as Device types
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Vincent Medical (Dong Guan) Manufacturing Co., Ltd. Dong Guan Guangdong Contract manufacturer 29
Sanbor Medical Xiamen, Inc. Xiamen Fujian Contract manufacturer 16
Intersurgical Medical Apparatus (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 12
Ningbo Tianyi Medical Appliance Co., Ltd. Ningbo Zhejiang Contract manufacturer 11
GVS Technology (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 5
Flexible Circuit Technologies Shenzhen Shenzhen Guangdong Contract manufacturer 1
Changshu Rozer Sterilization Technology Co., Ltd. Changshu Jiangsu Contract manufacturer 43
Rozer Sterilization Technology Shuyang Company Limited Shuyang Jiangsu Contract manufacturer 33
Feellife Health Inc. Shenzhen Guangdong Contract manufacturer 8

Record

Regulatory record for Polytech Filter
Listed by Polytechnic Resources, Inc., United States
FDA product code BZG
Device type Spirometer, Diagnostic
Device class Class 2
Regulation 21 CFR 868.1840
Establishment Manufacturer
510(k) K042758
Record published 2016-11-15
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Over the counter Yes
Supplied as a kit Yes
Latex Contains natural rubber latex
Label carries manufacturing date, serial number
Sizes Outer diameter 28.4 to 48.6 mm; outer diameter 30.1 µm

Catalogue Numbers

Catalogue numbers for Polytech Filter
Catalogue number Size Per pack Status
756TMN Outer Diameter 48.6 mm 100 In distribution
790S 100 In distribution
756T Outer Diameter 48.6 mm 100 In distribution
PR022454 Outer Diameter 28.4 mm 100 In distribution
EBS757NKNW Outer Diameter 34.3 mm 100 In distribution
100757SW Outer Diameter 34.3 mm 100 In distribution
757T Outer Diameter 34.3 mm 100 In distribution
P5551100 Outer Diameter 30.1 mm 100 In distribution
EBS780NW Outer Diameter 34.3 mm 100 In distribution
100780E2 Outer Diameter 34.3 mm 100 In distribution
TNN102 Outer Diameter 34.3 mm 100 In distribution
P5553100 Outer Diameter 48.6 mm 100 In distribution
100756NG Outer Diameter 48.6 mm 100 In distribution
S100758NW Outer Diameter 28.4 mm 100 In distribution
100790E2 Outer Diameter 34.3 mm 100 In distribution
757S Outer Diameter 34.3 mm 100 In distribution
757EL 100 In distribution
100759K 100 In distribution
100760E2 Outer Diameter 38.8 mm 100 In distribution
100759NW Outer Diameter 30.1 mm 100 In distribution
100760S Outer Diameter 38.8 mm 100 In distribution
780W Outer Diameter 34.3 mm 100 In distribution
758EW Outer Diameter 28.4 mm 100 In distribution
756EB Outer Diameter 48.6 mm 100 In distribution
757W Outer Diameter 34.3 mm 100 In distribution
100756EB Outer Diameter 48.6 mm 100 In distribution
100760E Outer Diameter 38.8 mm 100 In distribution
100756NB Outer Diameter 48.6 mm 100 In distribution
760EL Outer Diameter 38.8 mm 100 In distribution
N100756NW Outer Diameter 48.6 mm 100 In distribution
100756EP Outer Diameter 48.6 mm 100 In distribution
FIL7958 Outer Diameter 34.3 mm 100 In distribution
P5558100 Outer Diameter 28.4 mm 100 In distribution
759EWM Outer Diameter 30.1 mm 100 In distribution
100757E2 Outer Diameter 34.3 mm 100 In distribution
756Y Outer Diameter 48.6 mm 100 In distribution
P5557100E Outer Diameter 34.3 mm 100 In distribution
PR772505MP Outer Diameter 34.3 mm 100 In distribution
100780 Outer Diameter 34.3 mm 100 In distribution
100757EP Outer Diameter 34.3 mm 100 In distribution
P5556100 Outer Diameter 28.4 mm 100 In distribution
757EP Outer Diameter 34.3 mm 100 In distribution
780E2 Outer Diameter 34.3 mm 100 In distribution
EBS757EB Outer Diameter 34.3 mm 100 In distribution
EBS757EW Outer Diameter 34.3 mm 100 In distribution
756W Outer Diameter 48.6 mm 100 In distribution
PFT830E Outer Diameter 34.3 mm 100 In distribution
757WMN Outer Diameter 34.3 mm 100 In distribution
759S Outer Diameter 30.1 mm 100 In distribution
759E2 Outer Diameter 30.1 mm 100 In distribution
756G Outer Diameter 48.6 mm 100 In distribution
S100757NKNW Outer Diameter 34.3 mm 100 In distribution
PMP756NX Outer Diameter 48.6 mm 100 In distribution
760E2 Outer Diameter 38.8 mm 100 In distribution
100756SW Outer Diameter 48.6 mm 100 In distribution
757E2 Outer Diameter 34.3 mm 100 In distribution
FIL9000 Outer Diameter 34.3 mm 100 In distribution
100757NP Outer Diameter 34.3 mm 100 In distribution
100760eln Outer Diameter 38.8 mm 100 In distribution
100757NT Outer Diameter 34.3 mm 100 In distribution
100756NP Outer Diameter 48.6 mm 100 In distribution
758E2 Outer Diameter 28.4 mm 100 In distribution
756B Outer Diameter 48.6 mm 100 In distribution
100756E2 Outer Diameter 48.6 mm 100 In distribution
760W Outer Diameter 38.8 mm 100 In distribution
760ELMN Outer Diameter 38.8 mm 100 In distribution
100758NKNW Outer Diameter 28.4 mm 100 In distribution
100757NW Outer Diameter 34.3 mm 100 In distribution
M100780E2 Outer Diameter 34.3 mm 100 In distribution
759EL Outer Diameter 30.1 mm 100 In distribution
100756NY 100 In distribution
100759EW Outer Diameter 30.1 mm 100 In distribution
EBS756NX Outer Diameter 48.6 mm 100 In distribution
756ELMN Outer Diameter 48.6 mm 100 In distribution
N100756NKNS Outer Diameter 48.6 mm 100 In distribution
100780NKNW Outer Diameter 34.3 mm 100 In distribution
756EL Outer Diameter 48.6 mm 100 In distribution
757ELMSN Outer Diameter 34.3 mm 100 In distribution
100790W Outer Diameter 34.3 mm 100 In distribution
Samples Outer Diameter 34.3 mm 10 In distribution
P5557100 Outer Diameter 34.3 mm 100 In distribution
TNN101 Outer Diameter 30.1 mm 100 In distribution
758WM Outer Diameter 28.4 mm 100 In distribution
757EW Outer Diameter 34.3 mm 100 In distribution
PMP757NW Outer Diameter 34.3 mm 100 In distribution
S100756EW Outer Diameter 48.6 mm 100 In distribution
P5551100S Outer Diameter 30.1 mm 100 In distribution
100757NG Outer Diameter 34.3 mm 100 In distribution
100758NW 100 In distribution
100760EN Outer Diameter 38.8 mm 100 In distribution
100758EW Outer Diameter 28.4 mm 100 In distribution
N100758NKNW Outer Diameter 28.4 mm 100 In distribution
PFT851 Outer Diameter 30.1 mm 100 In distribution
756E2 Outer Diameter 48.6 mm 100 In distribution
PFT851E Outer Diameter 30.1 mm 100 In distribution
EBS756NP Outer Diameter 48.6 mm 100 In distribution
100758E2 Outer Diameter 28.4 mm 100 In distribution
100759KN 100 In distribution
100760WN Outer Diameter 38.8 mm 100 In distribution
PFT830 100 In distribution
EBS757NW Outer Diameter 34.3 mm 100 In distribution
100758NK Outer Diameter 28.4 mm 100 In distribution
N100758NW Outer Diameter 28.4 mm 100 In distribution
780WMN Outer Diameter 34.3 mm 100 In distribution
100760KN 100 In distribution
100757EB Outer Diameter 34.3 mm 100 In distribution
P5556100E Outer Diameter 28.4 mm 100 In distribution
100760 Outer Diameter 38.8 mm 100 In distribution
N100758NKNS Outer Diameter 28.4 mm 100 In distribution
PUL9000K Outer Diameter 34.5 mm 100 In distribution
100780K Outer Diameter 34.3 mm 100 In distribution
780EW Outer Diameter 34.3 mm 100 In distribution
100757EW Outer Diameter 34.3 mm 100 In distribution
PR772505 Outer Diameter 34.3 mm 100 In distribution
EBS756EB Outer Diameter 48.6 mm 100 In distribution
790W Outer Diameter 34.3 mm 100 In distribution
S100758NK Outer Diameter 28.4 mm 100 In distribution
759W Outer Diameter 30.1 µm 100 In distribution
790EL Outer Diameter 34.3 mm 100 In distribution
M100780W Outer Diameter 34.3 mm 100 In distribution
EBS758NNK Outer Diameter 28.4 mm 100 In distribution
100759E2 Outer Diameter 30.1 mm 100 In distribution
PUL9000E Outer Diameter 34.5 mm 100 In distribution
100756EW Outer Diameter 48.6 mm 100 In distribution
P5553100E Outer Diameter 48.6 mm 100 In distribution
EBS756NG Outer Diameter 48.6 mm In distribution
EBS756EW Outer Diameter 48.6 mm 100 In distribution
100759SW Outer Diameter 30.1 mm 100 In distribution
756EW Outer Diameter 48.6 mm 100 In distribution
100757NY Outer Diameter 34.3 mm 100 In distribution
100790S Outer Diameter 34.3 mm 100 In distribution
100780EW 100 In distribution
S100758NKNW Outer Diameter 28.4 mm 100 In distribution
P5551100E Outer Diameter 30.1 mm 100 In distribution
100757NK Outer Diameter 34.3 mm 100 In distribution
759WM Outer Diameter 30.1 mm 100 In distribution
PUL9000N Outer Diameter 34.5 mm 100 In distribution
100790E Outer Diameter 34.3 mm 100 In distribution
EBS756NW Outer Diameter 48.6 mm 100 In distribution
100757NKNW 100 In distribution
S100759EW Outer Diameter 30.1 mm 100 In distribution
759EW Outer Diameter 30.1 mm 100 In distribution
760WM Outer Diameter 38.8 mm 100 In distribution
758EL Outer Diameter 28.4 mm 100 In distribution
100760EL Outer Diameter 38.8 mm 100 In distribution
EBS756EX Outer Diameter 48.6 mm 100 In distribution
100780EL Outer Diameter 38.8 mm 100 In distribution
PMP756EX Outer Diameter 48.6 mm 100 In distribution
PR022462 Outer Diameter 28.4 mm 100 In distribution
757ELMN Outer Diameter 34.3 mm 100 In distribution
100757EN Outer Diameter 34.3 mm 100 In distribution
790E2 Outer Diameter 30.3 mm 100 In distribution
756P Outer Diameter 48.6 mm 100 In distribution
100756NT Outer Diameter 48.6 mm 100 In distribution
758WMN Outer Diameter 28.4 mm 100 In distribution
P5554100 Outer Diameter 34.3 mm 100 In distribution
756P 100 In distribution
100759EN 100 In distribution
100790EL Outer Diameter 34.3 mm 100 In distribution
TNN103 Outer Diameter 48.6 mm 100 In distribution
757WM Outer Diameter 34.3 mm 100 In distribution
100756EL Outer Diameter 48.6 mm 100 In distribution
EBS759WC Outer Diameter 34.3 mm 100 In distribution
780EL Outer Diameter 34.3 mm 100 In distribution
757G Outer Diameter 34.3 mm 100 In distribution
100756NW Outer Diameter 48.6 mm 100 In distribution
100757EL Outer Diameter 34.3 mm 100 In distribution
790WM Outer Diameter 34.3 mm 100 In distribution
757EB Outer Diameter 34.3 mm 100 In distribution
EBS756NB Outer Diameter 48.6 mm 100 In distribution
M100780EW Outer Diameter 34.3 mm 100 In distribution
100760K Outer Diameter 38.8 mm 100 In distribution
P5559100E Outer Diameter 38.8 mm 100 In distribution
EBS758NW Outer Diameter 28.4 mm 100 In distribution
P5559100 Outer Diameter 38.8 mm 100 In distribution
S100757NW Outer Diameter 34.3 mm 100 In distribution
100790K Outer Diameter 34.3 mm 100 In distribution
P5554100E Outer Diameter 34.3 mm 100 In distribution
S100756NW Outer Diameter 48.6 mm 100 In distribution
759ELMN Outer Diameter 30.1 mm 100 In distribution
100757NB Outer Diameter 34.3 mm 100 In distribution
759WMN Outer Diameter 30.1 mm 100 In distribution
758W Outer Diameter 28.4 mm 100 In distribution
760EW Outer Diameter 38.8 mm 100 In distribution
S100758EL Outer Diameter 28.4 mm 100 In distribution
M100780EL Outer Diameter 34.3 mm 100 In distribution
PFT819 Outer Diameter 48.6 mm 100 In distribution
756EP Outer Diameter 48.6 mm 100 In distribution
100759WC Outer Diameter 30.1 mm 100 In distribution
PFT819E Outer Diameter 48.6 mm 100 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Model 4000 Vitalograph Ireland Ltd. 115
Astra Spirometer S D I Diagnostics Inc 90
MIR Mir Medical International Research 56
Curaplex TRI-Anim Health Services, Inc. 55
Alpha Vitalograph Ireland Ltd. 48
Welch Allyn, Inc. Welch Allyn, Inc. 47
MGC Diagnostics Medical Graphics Corp. 42
Astraguard S D I Diagnostics Inc 39
PFT Vitalograph Ireland Ltd. 38
Vyaire Jaeger Medical GmbH 36
BVF Vitalograph Ireland Ltd. 29
Micro Medical Jaeger Medical GmbH 25

Showing 12 of 123. All products under Spirometer, Diagnostic

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K042758 2005-08-29

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