FDA.report

MEDLINE

Primary DI
20197344018533
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
945638145
Catalog number
945638145
Device description
FDS,72,NV,CHAMBER,YELLOW
Published
2023-09-15
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

Product Codes

CodeName
FPASet, administration, intravascular

Product Code Classifications

CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions

SubmissionSupplement
K852140000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K852140000NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS)North American Instrument Corp.1985-05-30FPA

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20197344018533PackageGS125In Commercial Distribution
30197344018530PackageGS1100In Commercial Distribution
10197344018536PrimaryGS10

GMDN Terms

TermDefinition
Basic intravenous administration set, noninvasiveA collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)626-4255NAMICQUALITY@MEDLINE.COM

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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