Dragerwerk AG
FDA registration: United States Last updated 23 May 2026
- Devices
- 699
- Registries
- EUDAMEDGUDID
- FDA recalls
- 0
Catalogue
Vario Vac B NF MP00503 Ref MP00503
Mask ClassicStar, NIV, w/AAV, M MP01571 Ref MP01571
VentStar Bag Set 150 (Cone OD22) MP16019 Ref MP16019
VentStar Bag Set (N) 110 MP00383 Ref MP00383
NBP Cuff M, 23-33cm MP00915 Ref MP00915
ECG limb wires, 3-lead, IEC 2606493 Ref 2606493
VarioVac B AGA MP00504 Ref MP00504
Ventstar ID coax WT GSL 210 MP00367 Ref MP00367
APack Flex Adult, CS Mask Stan5 MP01680 Ref MP01680
Infinity ID CLIC absorber Free MX50120 Ref MX50120
ErgoStar CM 60 MP01860 Ref MP01860
Breathing bag 2.3L ISO silicon 2166062 Ref 2166062
VarioVac MRI P rail MP03223 Ref MP03223
Infinity ID Flow Sensor 6871980 Ref 6871980
Anesthesia ID Set Coax GSL 230 MP00368 Ref MP00368
NeoMask M (pack of 10pcs) 8418490 Ref 8418490
Mask ClassicStar, NIV, SE, S MP01573 Ref MP01573
Anesth Set Coax GSL 230 (BagCone OD22) MP16049 Ref MP16049
Filter/HME TwinStar 90 Plus MP05800 Ref MP05800
Vapor 3000 M36500 Ref M36500
Breathing hose 22/22 (A) 300 2112760 Ref 2112760
Cap (7 Mm) 8401645 Ref 8401645
Mask Silicone PremieXS 00 reus MP02900 Ref MP02900
Mask tracheostomy O2Star M/L MP01924 Ref MP01924
BlueSet Anesthesia WT (P/A) MK04248 Ref MK04248
Hose 10x3-SI NF 1207741 Ref 1207741
ECG 6-Lead TruST AHA/US, Telem MP03426 Ref MP03426
Filter SafeStar 60A Plus MP05795 Ref MP05795
Anesthesia Circuit Kit Flex 6 MP02744 Ref MP02744
Hose, Light 0, 25 M 8410817 Ref 8410817
Inf.ID Breath.CircuitSm. 150 MP04803 Ref MP04803
Headgaer disp., soft fabric, la. MP01560 Ref MP01560
Carina VPack NIV ClasS Fullf M MP01664 Ref MP01664
Positioning Aid Hug It, Size S MP01415 Ref MP01415
Y-Piece 90DEGREE 8403075 Ref 8403075
ECG 5-Leads single pin AHA 1.5m 2612003 Ref 2612003
ID Coax 230 MP03377 Ref MP03377
Dummy Plug (F.y-Piece 8405435) 8410049 Ref 8410049
Anesthesia Set Coax WT GSL 210 MP00359 Ref MP00359
Adapter NBP MP00957 Ref MP00957
Single_Pat_Use_ECG_3_Lead_IEC2 MP00877 Ref MP00877
Cap L (large a 5pcs) 8418536 Ref 8418536
VentStar Basic US MP00320 Ref MP00320
Mask LiteStar 4 w/o hook MP11004 Ref MP11004
Infinity ID CLIC absorber 800+ MX50004 Ref MX50004
Fabius Tiro D-M 8608400 Ref 8608400
Breathing hose 22/22 (A) 110 2166038 Ref 2166038
NBP Cuff L, 31-40cm, Box10 MP00931 Ref MP00931
ID Circuit Coax w. holder MP00342 Ref MP00342
Filter/HME TwinStar HEPA Plus MP05801 Ref MP05801
Showing 201-250 of 699
What Dragerwerk AG makes
Dragerwerk AG manufactures medical equipment including oxymeters and the Incubator 8000 and Incubator 8000 IC models.
These devices are classified as Class II medical products and are listed in the FDA 510(k) registry, with the company maintaining operations in the US.
Frequently asked questions
What types of medical equipment does Dragerwerk AG manufacture?
Dragerwerk AG manufactures a range of medical equipment designed for clinical environments. Their product portfolio includes oxymeters as well as the Incubator 8000 and Incubator 8000 IC models, which are specialized devices used for patient care.
Where is Dragerwerk AG based?
Dragerwerk AG maintains operations within the United States. This location serves as the base for their activities related to the medical devices they manufacture and distribute.
How are the medical devices from Dragerwerk AG classified?
The medical devices produced by Dragerwerk AG, specifically the oxymeters and the Incubator 8000 series, are classified as Class II medical products. This classification is based on the regulatory framework applied to these specific types of equipment.
In which registries are the devices from Dragerwerk AG listed?
The medical devices manufactured by Dragerwerk AG are listed in the FDA 510(k) registry. This registry tracks devices that have undergone the 510(k) submission process to demonstrate their regulatory status in the United States.
Information
- FDA registration
- United States