FDA.reportPublic FDA data

REPEATER

Primary DI
50085412476518
Brand
REPEATER
Company
BAXTER CORPORATION ENGLEWOOD
Model
H93813
Catalog number
H93813
Device description
REPEATER Pump Fluid Transfer Tube Set, Non-Sterile
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K872743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K872743000BAXA TUBING SETS (FOR PHARMACY PUMP)Baxa Corp., Sub. of Cook Group, Inc.1987-10-09FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50085412476518PackageGS110In Commercial Distribution
00085412476513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5008541247651850085412476518
00085412476513000854124765130854124765130085412476513

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)933-0303Medinfo_medproducts@baxter.com

Regulatory Flags#

DUNS number
078383477
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085412478425TWOFERH93819035H938190352016-09-24
00085412476681REPEATERH93862H938622016-09-23
00085412476698REPEATERH93863H938632016-09-23
00085412477466EXACTAMIXH938901H9389012016-09-23
00085412492001EXACTAMIXH938G792H938G7922016-09-23
00085412492117EXACTAMIXH938G724H938G7242016-09-23
05413765492013EXACTAMIXH938G173H938G1732016-09-23
05413765492020EXACTAMIXH938G174H938G1742016-09-23
05413765492037EXACTAMIXH938G175H938G1752016-09-23
05413765492044EXACTAMIXH938G176H938G1762016-09-23
00085412476513REPEATERH93813H938132016-09-23
00085412476599REPEATERH93812H938122016-09-23
00085412476841REPEATERH93887H938872016-09-23
00085412480664NAH93813MPIH93813MPI2016-09-23
00085412481401NAH9389BTSH9389BTS2016-09-23
00085412476865NAH93891H938912016-09-23
50085412478321RAPIDFILLH93813701H938137012016-09-23
50085412478369RAPIDFILLH93813901H938139012016-09-23
50085412478376RAPIDFILLH93813915H938139152016-09-23
00085412478401TWOFERH93816045H938160452016-09-24

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Primary DI, Brand, Company table
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