Dead End Stopper & Cap

Primary DI
00616784705736
Brand
Dead End Stopper & Cap
Company
DYNAREX CORPORATION
Model
7057
Published
2018-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMGStopcock, I.V. Set

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMGStopcock, I.V. SetGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172266000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172266000Dynarex Three-Way StopcockDynarex Corporation2018-03-14FMG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784705736PackageGS12000In Commercial Distribution
00616784705729PrimaryGS10
00616784705712Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784705736006167847057366167847057360616784705736
00616784705729006167847057296167847057290616784705729
00616784705712006167847057126167847057120616784705712

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous line stopcockA sterile valve that is typically a component of an intravenous (IV) administration set and designed to be manually-operated by healthcare staff to regulate the flow of intravenous solution delivered to a patient. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
200
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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