Maquet Critical Care Ab

FDA Filings

This page includes the latest FDA filings for Maquet Critical Care Ab. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 8010042
• FEI Number: 3002808128
• Name: MAQUET CRITICAL CARE AB
• Owner & Operator: MAQUET CRITICAL CARE AB
• Contact Address: ROENTGENVAGEN 2 --; SOLNA SE-AB Stockholms lan [SE-01] SE-17154 SE
• Official Correspondent:
  • Dennis - Genito
  • 046-70-7827852-x
• US Agent:
  • Dennis Genito
  • Maquet Cardiovascular
  • 973 7097515
  • 973 8071658
  • Dennis.genito@Getinge.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: ROENTGENVAGEN 2 ; SOLNA Stockholms lan [SE-01], S-17154 SE
• Establishment Type:
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 07325710012673 Maquet Critical Care AB	Drawer for Low mobile carts	2023-12-18
GUDID 07325710015117 Maquet Critical Care AB	Servo-air Lite	2023-09-29
GUDID 07325710001653 Maquet Critical Care AB	Compressor Mini 115V 60Hz	2023-09-29
GUDID 07325710010518 Maquet Critical Care AB	Base Unit Servo-u MR	2021-12-09
GUDID 07325710012185 Maquet Critical Care AB	Heliox Servo adapter kit	2021-06-28
PMN K201874 Maquet Critical Care AB	Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1	2021-04-20
GUDID 17325710004248 Maquet Critical Care AB	Dust filter 20 pcs/pkg	2020-09-24
GUDID 07325710011331 Maquet Critical Care AB	Humidifier holder for rail 10 x 25/10 x 30 mm	2020-09-24
GUDID 07325710004906 Maquet Critical Care AB	Cabinet	2020-09-24
GUDID 07325710004210 Maquet Critical Care AB	Support arm 179	2020-09-24
GUDID 07325710004166 Maquet Critical Care AB	Shelf base, Servo-air	2020-09-24
GUDID 07325710004159 Maquet Critical Care AB	Mobile Cart, Flat Pack Servo-air	2020-09-24
GUDID 07325710003909 Maquet Critical Care AB	Battery module	2020-09-24
GUDID 07325710003114 Maquet Critical Care AB	Base unit, Servo-air	2020-09-24
GUDID 07325710001189 Maquet Critical Care AB	Air inlet filter	2020-09-24
GUDID 07325710012420 Maquet Critical Care AB	AFGO kit (onsite upgrade)	2020-06-03
GUDID 07325710011577 Maquet Critical Care AB	CO2 absorber (disposable), 12 pcs/pkg	2020-06-03
GUDID 07325710010860 Maquet Critical Care AB	Extra Volume reflector	2020-06-03
GUDID 07325710010631 Maquet Critical Care AB	Flow-i C40 Anesthesia System	2020-06-03
GUDID 07325710010624 Maquet Critical Care AB	Flow-i C30 Anesthesia System	2020-06-03
GUDID 07325710010617 Maquet Critical Care AB	Flow-i C20 Anesthesia System	2020-06-03
GUDID 07325710010464 Maquet Critical Care AB	AFGO adapter kit onsite upgrade	2020-06-03
GUDID 07325710010457 Maquet Critical Care AB	Flow-e Anesthesia System	2020-06-03
GUDID 07325710009895 Maquet Critical Care AB	Suction tip holder	2020-06-03
GUDID 07325710009888 Maquet Critical Care AB	Tubing hook small	2020-06-03
GUDID 07325710009871 Maquet Critical Care AB	Tubing hook large	2020-06-03
GUDID 07325710009864 Maquet Critical Care AB	Flexible manual breathing bag arm	2020-06-03
GUDID 07325710009819 Maquet Critical Care AB	Horizontal short rail DIN	2020-06-03
GUDID 07325710009789 Maquet Critical Care AB	Volume reflector	2020-06-03
GUDID 07325710009642 Maquet Critical Care AB	Vaporizer Sevoflurane, SAFE-T-SEAL	2020-06-03
GUDID 07325710008430 Maquet Critical Care AB	Vaporizer Sevoflurane, MAQUET filling	2020-06-03
GUDID 07325710008423 Maquet Critical Care AB	Vaporizer Desflurane, Saf-Fil	2020-06-03
GUDID 07325710008416 Maquet Critical Care AB	Vaporizer Isoflurane, MAQUET filling	2020-06-03
GUDID 07325710008409 Maquet Critical Care AB	Vaporizer Sevoflurane, QUICK FILL	2020-06-03
GUDID 07325710001530 Maquet Critical Care AB	Volu.reflec, incl.Reflector socket	2020-04-07
PMN K191027 | BSZ MAQUET CRITICAL CARE AB	Flow Family Anesthesia System 4.7; Models Flow-c, Flow-e, Flow-i	2020-03-26
PMN K191027 Maquet Critical Care AB	Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System	2020-03-18
GUDID 17325710002565 Maquet Critical Care AB	Hytrel slang 10mm 30cm	2019-12-11
GUDID 07325710002896 Maquet Critical Care AB	Flextub Hytrel 15mm 15cm	2019-12-11
GUDID 07325710002230 Maquet Critical Care AB	Breath syst 10mm Heater Humidif.Si	2019-12-11
GUDID 07325710001950 Maquet Critical Care AB	Breath syst 10mm (Aktive Humid)Hytr	2019-12-11
GUDID 07325710001943 Maquet Critical Care AB	Breath syst 15mm (Aktive Humid)Hytr	2019-12-11
GUDID 07325710001936 Maquet Critical Care AB	Pat syst 10mm HME Hytrel Reus 1.5m	2019-12-11
GUDID 07325710001899 Maquet Critical Care AB	Breath syst 10mm (Aktive Humid)Sili	2019-12-11
GUDID 07325710001851 Maquet Critical Care AB	Pat syst 15mm HME Hytrel Reus 1.5m	2019-12-11
GUDID 07325710001844 Maquet Critical Care AB	Pat syst 22mm HME HME Si Reus 1.5m	2019-12-11
GUDID 07325710001820 Maquet Critical Care AB	Pat syst 22mm HME Hytrel Reus 1.5m	2019-12-11
GUDID 17325710002619 Maquet Critical Care AB	Breathing system 15mm HME Disp 1.2m	2019-11-27
GUDID 17325710002503 Maquet Critical Care AB	Breath circuit 10 disp 1.2m	2019-11-27
GUDID 17325710002473 Maquet Critical Care AB	Breath syst 10mm Act Disp 2.2m10pcs	2019-11-27
GUDID 17325710002459 Maquet Critical Care AB	Breath syst 22mm HME & MR 3M Disp	2019-11-27
GUDID 17325710002428 Maquet Critical Care AB	Breath syst 10mm HME Disp1.2m	2019-11-27
GUDID 17325710002336 Maquet Critical Care AB	Breath syst 10mm HME & MR 3M Disp	2019-11-27
GUDID 17325710002299 Maquet Critical Care AB	Breath syst 15mm HME & MR 3M Disp	2019-11-27
GUDID 17325710002268 Maquet Critical Care AB	Breath circuit 15 disp 1.2m	2019-11-27
GUDID 17325710002244 Maquet Critical Care AB	Breath circuit 22 disp 1.5m	2019-11-27
GUDID 17325710002169 Maquet Critical Care AB	Breathing system 22mm HME Disp 1.5m	2019-11-27
GUDID 17325710000127 Maquet Critical Care AB	Breath syst 22mm Act Disp2.1m 10pcs	2019-11-27
GUDID 07325710002766 Maquet Critical Care AB	Breath syst 22mm Heater Humidif.Si	2019-11-27
GUDID 07325710002032 Maquet Critical Care AB	Breath syst 22mm (Aktive Humid)Sili	2019-11-27
GUDID 07325710001837 Maquet Critical Care AB	Breath syst 22mm (Aktive Humid)Hytr	2019-11-27
PMN K182862 Maquet Critical Care AB	Servo Guard	2019-10-21
GUDID 17325710006549 Maquet Critical Care AB	Guide Wire for Edi catheter 6Fr/ 49 and 50 cm	2019-09-30
GUDID 17325710006525 Maquet Critical Care AB	Guide Wire for Edi catheter 8Fr/125 cm	2019-09-30
GUDID 07325710006535 Maquet Critical Care AB	Guide Wire for Edi catheter 8Fr/100 cm	2019-09-30
GUDID 17325710004200 Maquet Critical Care AB	Y sensor neonatal, disposable, 5 pcs/pkg	2019-05-28
GUDID 17325710002572 Maquet Critical Care AB	Y SENSOR PRESSURE LINE	2019-05-28
GUDID 17325710002190 Maquet Critical Care AB	THERMOSHELL, EXP CASSETTE	2019-05-28
GUDID 17325710001971 Maquet Critical Care AB	Y-PIECE W/SAMPL. PORT	2019-05-28
GUDID 07325710009796 Maquet Critical Care AB	CO2 ANALYZER MODULE CAPNOSTAT 5	2019-05-28
GUDID 07325710005705 Maquet Critical Care AB	GAS CYLINDER RESTRAINER KIT US	2019-05-28
GUDID 07325710004289 Maquet Critical Care AB	Universal Holder assy	2019-05-28
GUDID 07325710004265 Maquet Critical Care AB	Rail clamp 10x25, Humidifier holder	2019-05-28
GUDID 07325710004258 Maquet Critical Care AB	Humidification holder assy	2019-05-28
GUDID 07325710004180 Maquet Critical Care AB	CAPNOSTAT 5	2019-05-28
GUDID 07325710002971 Maquet Critical Care AB	Y PIECE HOLDER/HOOK SERVO VENT HANDL	2019-05-28
GUDID 07325710002889 Maquet Critical Care AB	CO2 ANALYZER MODULE	2019-05-28
GUDID 07325710002711 Maquet Critical Care AB	WATERBAG/IV POLE	2019-05-28
GUDID 07325710001042 Maquet Critical Care AB	Base Unit SERVO-n	2019-05-28
GUDID 07325710000786 Maquet Critical Care AB	MOBILE CART	2019-05-28
GUDID 07325710000762 Maquet Critical Care AB	PENDANT BED/HOLDER	2019-05-28
GUDID 07325710000748 Maquet Critical Care AB	SHELF BASE	2019-05-28
GUDID 07325710000724 Maquet Critical Care AB	HUMIDIFIER HOLDER	2019-05-28
GUDID 07325710000717 Maquet Critical Care AB	USER INTERFACE HOLDER	2019-05-28
GUDID 07325710000670 Maquet Critical Care AB	CABLE HOLDER	2019-05-28
GUDID 07325710000663 Maquet Critical Care AB	Support Arm 178	2019-05-28
GUDID 07325710000304 Maquet Critical Care AB	Y sensor module, SERVO-U/-n	2019-05-28
GUDID 07325710000250 Maquet Critical Care AB	TELEFLEX ADAPTER, HUMIDIFIER HOLDER	2019-05-28
GUDID 17325710004149 Maquet Critical Care AB	EXPIRATORY CASSETTE, DARK GRAY	2019-04-17
GUDID 17325710004132 Maquet Critical Care AB	EXPIRATORY CASSETTE, SERVO-n	2019-04-17
GUDID 07325710001110 Maquet Critical Care AB	BASE UNIT SERVO-U	2019-04-17
PMN K180098 | CBK MAQUET CRITICAL CARE AB	Servo-u/n	2019-03-27
PMN K180098 Maquet Critical Care AB	SERVO-U Ventilator System Version 2.1; SERVO-n Ventilator System Version 2.1	2019-03-19
GUDID 07325710003329 Maquet Critical Care AB	High Pressure hose Heliox NIST 5m	2018-12-21
GUDID 17325710004576 Maquet Critical Care AB	Servo duo guard 1pcs	2018-10-10
GUDID 17325710004569 Maquet Critical Care AB	Servo Guard 1pcs	2018-10-10
GUDID 17325710003487 Maquet Critical Care AB	Absorber sealing, 2 each	2018-07-06
GUDID 17325710003463 Maquet Critical Care AB	Water Trap Dryline A KMG2000 10each	2018-07-06
GUDID 17325710003166 Maquet Critical Care AB	Sampling Line 2,5m 25Pc	2018-07-06
GUDID 07325710004098 Maquet Critical Care AB	Patient cassette complete	2018-07-06
GUDID 07325710002742 Maquet Critical Care AB	GAS CYLINDER RESTRAINER KIT	2018-07-06
GUDID 07325710001141 Maquet Critical Care AB	Vaporizer Sevoflurane, QUIK FIL	2018-07-06
GUDID 07325710001134 Maquet Critical Care AB	Vaporizer Isoflur. Maquet filling	2018-07-06
GUDID 07325710000458 Maquet Critical Care AB	Conn Tube 22mm Int 50m disposable	2018-07-06
GUDID 07325710000397 Maquet Critical Care AB	Adjustable arm for param. modules	2018-07-06
GUDID 07325710000212 Maquet Critical Care AB	Vaporizer Sevoflur. Maquet filling	2018-07-06
PMN K160665 | BSZ MAQUET CRITICAL CARE AB	FLOW-i 4.2	2017-03-31
PMN K153688 | PIF MAQUET CRITICAL CARE AB	Edi Catheter ENFit	2017-03-31
PMN K153688 | CBK MAQUET CRITICAL CARE AB	Edi Catheter ENFit	2017-03-31
PMN K160665 MAQUET CRITICAL CARE AB	FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40	2017-03-29
PMN K153688 MAQUET CRITICAL CARE AB	Edi Catheter ENFit	2017-03-02
PMN K151814 | CBK MAQUET CRITICAL CARE AB	SERVO-U/n	2015-12-22
PMN K151814 MAQUET CRITICAL CARE AB	SERVO-U Ventilator System, SERVO-n Ventilator System	2015-12-21
PMN K153461 MAQUET CRITICAL CARE AB	Guide Wire For Edi Catheter 6 Fr, Guide Wire For Edi Catheter 8 Fr, 100 Cm, Guide Wire For Edi Catheter 8 Fr, 125 Cm	2015-12-11
PMN K033710 | BTT MAQUET CRITICAL CARE AB	MR850	2015-10-27
BSF MAQUET CRITICAL CARE AB	Absorber FLOW-i	2015-10-16
CAT MAQUET CRITICAL CARE AB	Miniflow adapter Nasal prongs size XS, S, M, M-wide, L, XL, L-wide	2015-05-28
PMN K133958 | BSZ MAQUET CRITICAL CARE AB	FLOW-i C40	2015-02-06
PMN K133958 | BSZ MAQUET CRITICAL CARE AB	FLOW-i C30	2015-02-06
PMN K133958 | BSZ MAQUET CRITICAL CARE AB	FLOW-i C20	2015-02-06
PMN K123149 MAQUET CRITICAL CARE AB	SERVO-I VENTILATOR SYSTEM	2014-06-20
PMN K133958 MAQUET CRITICAL CARE AB	FLOW-I ANESTHESIA SYSTEM C20, C30 & C40	2014-03-20
BYD MAQUET CRITICAL CARE AB	Servo Humidifier 173	2013-06-26
BYD MAQUET CRITICAL CARE AB	Servo Humidifier 172	2013-06-26
BYD MAQUET CRITICAL CARE AB	Servo Humidifier 163	2013-06-26
BYD MAQUET CRITICAL CARE AB	Servo Humidifier 162	2013-06-26
BYD MAQUET CRITICAL CARE AB	Servo Humidifier 161	2013-06-26
CAI MAQUET CRITICAL CARE AB	Set of breathing circuit anesthesia	2012-08-31
CAI MAQUET CRITICAL CARE AB	Gas samplning line	2012-08-31
CAI MAQUET CRITICAL CARE AB	Breathing system	2012-08-31
CAI MAQUET CRITICAL CARE AB	Breathing circuit	2012-08-31
BYH MAQUET CRITICAL CARE AB	Watertrap reusable	2012-08-31
BTC MAQUET CRITICAL CARE AB	Breathing Bag set Anesthesia, Reusable	2012-08-31
BTC MAQUET CRITICAL CARE AB	Breathing Bag Anesthesia, Reusable	2012-08-31
BTC MAQUET CRITICAL CARE AB	Breathing Bag Anesthesia, Disposable	2012-08-31
BSJ MAQUET CRITICAL CARE AB	Anesthesia mask, Reusable	2012-08-31
BSJ MAQUET CRITICAL CARE AB	Anesthesia mask, Disposable	2012-08-31
PMN K112114 MAQUET CRITICAL CARE AB	MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40	2012-01-13
PMN K102182 MAQUET CRITICAL CARE AB	MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30	2011-05-09
PMN K101199 MAQUET CRITICAL CARE AB	GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER,	2010-08-27
PMN K073179 MAQUET CRITICAL CARE AB	SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585	2008-06-09
PMN K030071 | CAH MAQUET CRITICAL CARE AB	Servo Guard	2008-02-19
PMN K063404 MAQUET CRITICAL CARE AB	SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800	2007-02-15
PMN K062793 MAQUET CRITICAL CARE AB	SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION	2007-02-07
PMN K041223 MAQUET CRITICAL CARE AB	MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E	2004-07-29
PMN K040221 MAQUET CRITICAL CARE AB	SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E	2004-02-20

Related Finance Registrations

NCAGE Code	AC72N	MAQUET CRITICAL CARE AB
NCAGE Code	SW730	MAQUET CRITICAL CARE AB
CAGE Code	SW730	MAQUET CRITICAL CARE AB
CAGE Code	AC72N	MAQUET CRITICAL CARE AB