FDA.reportPublic FDA data

n.a.

Primary DI
04048551057223
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
13991SV
Device description
Air-Water Valve
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FDFColonoscope and accessories, flexible/rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551057223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551057223040485510572234048551057223

GMDN Terms#

Term, Definition table
TermDefinition
StopcockA general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. This is a single-use device.

Sterilization Methods#

Method table
Method
Peracetic Acid;Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide;Liquid Chemical

Regulatory Flags#

DUNS number
315731430
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048551232378n.a.27033U27033U2025-08-11
04048551232781n.a.27047B27047B2025-08-11
04048551418123n.a.TC304USTC304US2025-08-11
04048551210567n.a.8574GY8574GY2018-09-04
04048551210574n.a.8574GZ8574GZ2018-09-04
04048551211281n.a.8587K8587K2018-09-04
04048551211427n.a.8588K8588K2018-09-04
04048551211694n.a.8590KC8590KC2018-09-04
04048551425749n.a.40410LH40410LH2025-07-10
04048551425756n.a.40410LS40410LS2025-07-10
04048551425763n.a.40410LG40410LG2025-07-10
04048551425770n.a.40410LC40410LC2025-07-10
04048551425787n.a.40410LL40410LL2025-07-10
04048551425794n.a.40410LF40410LF2025-07-10
04048551425800n.a.40410LR40410LR2025-07-10
04048438008867NA051111-10051111-102025-03-28
04048438008911NA051110-10051110-102025-03-28
04048551010242NA497HCS497HCS2025-03-28
04048551012468NA11900RA11900RA2025-03-28
04048551061343NA20090331200903312025-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04953170467349ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UE160-AL5OLYMPUS MEDICAL SYSTEMS CORP.FDF2025-09-25
14547410477242FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
14547410477273FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
14547410477303FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
04953170425103COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-26
04953170425158COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-26
04961333356478PENTAX MedicalHOYA CORPORATIONFDF2025-04-28
04961333129430PENTAXHOYA CORPORATIONFDF2025-04-04
04961333172085PENTAXHOYA CORPORATIONFDF2025-04-04
84953170463910BALLOON3OLYMPUS MEDICAL SYSTEMS CORP.FDF2025-02-25
00850458007041GripTract-GI Endoscopic Tissue ManipulatorACTUATED MEDICAL, INC.FDF2025-01-16
04961333254620PENTAX MedicalHOYA CORPORATIONFDF2024-12-13
04953170465970EVIS EXERA III XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.FDF2024-11-25
06972520301094REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301100REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301117REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301124REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301179REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301186REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301193REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301209REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
04961333254781PENTAXHOYA CORPORATIONFDF2024-07-26
04961333254460PENTAXHOYA CORPORATIONFDF2024-07-26
04961333254811PENTAXHOYA CORPORATIONFDF2024-07-26
04961333254477PENTAXHOYA CORPORATIONFDF2024-07-26
04961333254798PENTAXHOYA CORPORATIONFDF2024-07-26
50724995228939DEFENDOMEDIVATORS INC.FDF2024-01-18
B369MES01019MEDISONOMedisono, LLCFDF2023-11-17
B369MES01020MEDISONOMedisono, LLCFDF2023-11-17
B369MES01021MEDISONOMedisono, LLCFDF2023-11-17