Koo Mfg Inc

FDA Filings

This page includes the latest FDA filings for Koo Mfg Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9616410
FEI Number3003413553
NameKOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD.
Owner & OperatorKOO MFG, INC.
Contact Address100 Zhongde Road Dakun Indurstrial Park
Songjiang CN-31 Shanghai 201613 CN
Official Correspondent
  • CHRISTOPHER - KOO
  • 86-21-5785841-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address100 Zhongde Road, Dakun Industrial Park
Songjiang Shanghai, 201614 CN
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Export Device to the United States But Perform No Other Operation on Device



Registration Number3007963782
FEI Number3007963782
NameKoo (Shanghai) Industries Co., Ltd
Owner & OperatorKOO MFG, INC.
Contact Address100 Zhongde Road Dakun Indurstrial Park
Songjiang CN-31 Shanghai 201613 CN
Official Correspondent
  • CHRISTOPHER - KOO
  • 86-21-5785841-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address100 Zhongde Road Dakun Industrial Park
Songjiang Shanghai, 201614 CN
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
Prostate Caddy?2015-04-28
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
Venturi Oxygen Mask2013-04-21
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
Venturi Mask2013-04-21
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
Tracheostomy Venturi Oxygen Mask2013-04-21
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
OXYGEN TUBING2010-01-28
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
FLEXI CRYSTAL AIRWAY MASK2007-01-26
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
CRYSTAL AIRWAY MASK2007-01-26
KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD. [KOO MFG, INC.]
FLEXI CRYSTAL AIRWAY MASK2007-01-26
KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD. [KOO MFG, INC.]
CRYSTAL AIRWAY MASK2007-01-26
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
MASK INFLATION BULB2006-04-27
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
Inflation Syringe for Rectal Balloon2006-04-27
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
BULB SYRINGES2006-04-27
KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD. [KOO MFG, INC.]
MASK INFLATION BULB2006-04-27
KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD. [KOO MFG, INC.]
Inflation Syringe for Rectal Balloon2006-04-27
KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD. [KOO MFG, INC.]
BULB SYRINGES2006-04-27
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
OXYGEN MASK, NON-REBREATHING2005-07-29
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
Elongated Non-Rebreather Oxygen Mask2005-07-29
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
OXYGEN NASAL CANNULA2005-07-29
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
First Breath Nasal Oxygen Cannula with male luer connector, tubing and oxygen connector2005-07-29
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
First Breath Nasal Oxygen Cannula with gas monitoring line, male luer connector, tubing, oxygen adapter2005-07-29
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
First Breath Nasal Oxygen Cannula with gas monitoring line, female luer connector, tubing, oxygen adapter2005-07-29
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
First Breath Nasal Oxygen Cannula with female luer connector, tubing and oxgyen adapter2005-07-29
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
First Breath Nasal Oxygen Cannula with ETCO2 monitoring2005-07-29
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
face tent2005-07-29
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
ZEPHIR MASK2005-07-29
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
Tracheostomy Mask2005-07-29
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
Oxygen Mask2005-07-29
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
Oxygen Mask with Reservoir Bag2005-07-29
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
MOONLIGHT NASAL2005-07-29
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
FISIOJET2005-07-29
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
Drainage Bag2005-07-29
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
Drainage Bag with 'T' connector2005-07-29
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
DELUXE NASAL2005-07-29
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
BLUESTAR PLUS FACE MASK2005-07-29
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
Aerosol Mask2005-07-29
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
AEROSOL2005-07-29
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
FACE MASK1999-12-13
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
CRYSTAL ANESTHESIA MASK1999-12-13
Koo (Shanghai) Industries Co., Ltd [KOO MFG, INC.]
ARIA BLOW MOLD MASK1999-12-13
KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD. [KOO MFG, INC.]
FACE MASK1999-12-13
KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD. [KOO MFG, INC.]
CRYSTAL ANESTHESIA MASK1999-12-13
KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD. [KOO MFG, INC.]
ARIA BLOW MOLD MASK1999-12-13

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