FDA.report

MEDLINE

Primary DI
40884389734385
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJMAN03
Catalog number
DYNJMAN03
Device description
MANIFOLD,3-PORT,RIGHT,HAND,ON,500,PSI
Published
2025-07-31
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

Related Records

Contact Domains

Product Codes

CodeName
DTLAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Product Code Classifications

CodeDeviceSpecialtyClass
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40884389734385PackageGS110In Commercial Distribution
10884389734384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4088438973438540884389734385
1088438973438410884389734384

GMDN Terms

TermDefinition
Infusion line manifoldA sterile, noninvasive device intended to provide multiple connections to an infusion fluid path. It consists of a straight-through infusion path with appropriate connectors at each end having multiple stopcock-controlled alternative connections to allow the injection/infusion of multiple different fluids/drugs. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
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10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
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10197344039784MEDLINEHNX20150HNX201502024-10-11
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10197344039845MEDLINEHNY19150HNY191502024-10-11
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10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

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