FDA.report

WATCHDOG™

Primary DI
08714729965794
Brand
WATCHDOG™
Company
BOSTON SCIENTIFIC CORPORATION
Model
H74939343A020
Catalog number
H74939343A020
Device description
Hemostasis Valve Kit
Published
2017-12-01
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

Related Records

Product Codes

CodeName
DQXWire, guide, catheter

Product Code Classifications

CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08714729965770PackageGS120In Commercial Distribution
08714729996019PackageGS15In Commercial Distribution
08714729965794PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08714729965770087147299657708714729965770
08714729996019087147299960198714729996019
08714729965794087147299657948714729965794

GMDN Terms

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

Regulatory Flags

DUNS number
021717889
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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08714729181248Percuflex™ BiliaryM005336402015-09-24
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