FDA.report

NAMIC

Primary DI
20193489068242
Brand
NAMIC
Company
MEDLINE INDUSTRIES, INC.
Model
90500050
Catalog number
90500050
Device description
PALESTRANT IRRIG.& DRAIN. SET-PKG
Published
2023-12-21
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
KGZACCESSORIES, CATHETER

Product Code Classifications

CodeDeviceSpecialtyClass
KGZAccessories, CatheterGeneral, Plastic Surgery1

Premarket Submissions

SubmissionSupplement
K896087000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K896087000PALESTRANT IRRIGATION AND DRAINAGE SETNorth American Instrument Corp.1989-11-03KGZ

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489068242PackageGS15In Commercial Distribution
10193489068245PrimaryGS10

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(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
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
true
Sterilization required before use
false

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