FDA.reportPublic FDA data

Viper II Blower Mister

Primary DI
00899054002272
Brand
Viper II Blower Mister
Company
KDL Medical, Inc.
Model
BLM-700MS
Device description
Blower Mister
Published
2017-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQHLavage, Jet

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974568000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974568000CHASE ANASTOMOSIS VISUALIZATION DEVICEChase Medical, Inc.1998-01-06FQH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00899054002272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00899054002272008990540022728990540022720899054002272

GMDN Terms#

Term, Definition table
TermDefinition
Surgical mist irrigation tipA device that is designed to deliver a combined stream of air and mist to clear blood from a specific area of a surgical site. This device is a special perforated tip which can be affixed to an appropriate kind of tubing that delivers the rinsing fluids. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
972-783-7005cust_svc@chasemedical.com

Regulatory Flags#

DUNS number
791048924
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00899054002005Sof-Flo Atraumatic Coronary Artery ShuntSHT-1210S2017-03-09
00899054002012Sof-Flo Atraumatic Coronary Artery ShuntSHT-1215S2017-03-14
00899054002029Bulb Tip Coronary Artery ShuntsSHB-1215S2017-03-09
00899054002036Bulb Tip Coronary Artery ShuntsSHB-3030S2017-03-14
00899054002043Bulb Tip Coronary Artery ShuntsSHB-3025S2017-03-14
00899054002050Bulb Tip Coronary Artery ShuntsSHB-3040S2017-03-14
00899054002074Sof-Flo Atraumatic Coronary Artery ShuntSHT-1213S2017-03-14
00899054002081Sof-Flo Atraumatic Coronary Artery ShuntSHT-1218S2017-03-14
00899054002104Sof-Flo Atraumatic Coronary Artery ShuntSHT-1220S2017-03-14
00899054002128Sof-Flo Atraumatic Coronary Artery ShuntSHT-1225S2017-03-14
00899054002135Bulb Tip Coronary Artery ShuntsSHB-1218S2017-03-14
00899054002159Bulb Tip Coronary Artery ShuntsSHB-1220S2017-03-14
00899054002173Bulb Tip Coronary Artery ShuntsSHB-1225S2017-03-14
00899054002180Bulb Tip Coronary Artery ShuntsSHB-1230S2017-03-14
00899054002265Viper II Apical LiftAPI-700VS2017-08-23
00899054002296Foot Pedal, Dual ValveFTV-10202017-08-24
00899054002302FasTract Sternal RetractorRTC-10002017-08-24
00899054002319FasTract Sternal Retractor, Deep BladesRTC-1000-C012017-08-24
00899054002401FasTract Modified Sternal Retractor, Deep BladesRTC-1000-C022017-08-24
00899054002418FasTract Suture StayRTC-1020S2017-08-24

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