FDA.reportPublic FDA data

Aseptic Fluid Transfer Set

Primary DI
10081317024948
Brand
Aseptic Fluid Transfer Set
Company
MENTOR TEXAS L.P.
Model
350-8400
Catalog number
350-8400
Device description
Aseptic Fluid Transfer Set
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
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAZTUBING, NONINVASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAZTubing, NoninvasiveGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K780417000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K780417000ASEPTIC TRANSFER SETHeyer Schulte Corp.1978-04-18GAZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10081317024948PackageGS14In Commercial Distribution
00081317024941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1008131702494810081317024948
00081317024941000813170249410813170249410081317024941

GMDN Terms#

Term, Definition table
TermDefinition
Fluid transfer set, general-purposeA collection of sterile devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)235-5731xx@xx.xx

Regulatory Flags#

DUNS number
167450993
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
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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Primary DI, Brand, Company table
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