FDA.report

NAMIC

Primary DI
20193489067320
Brand
NAMIC
Company
MEDLINE INDUSTRIES, INC.
Model
80621362
Catalog number
80621362
Device description
MTO PML 36 PEDIATRIC FLL-MLL - OEM
Published
2021-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DRIMONITOR, LINE ISOLATION

Product Code Classifications

CodeDeviceSpecialtyClass
DRIMonitor, Line IsolationCardiovascular1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489067320PackageGS1200In Commercial Distribution
40193489067348PrimaryGS10
10193489067347Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019348906732020193489067320
4019348906734840193489067348
1019348906734710193489067347

GMDN Terms

TermDefinition
StopcockA general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Ethylene Oxide

Contacts

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

Regulatory Flags

DUNS number
025460908
Device count
100
DM exempt
false
Premarket exempt
true
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
false
Sterilization required before use
true

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Other Devices Sharing Product Codes

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20193489068297NAMICMEDLINE INDUSTRIES, INC.DRI2023-12-21
20193489068303NAMICMEDLINE INDUSTRIES, INC.DRI2023-12-21
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20193489068556NAMICMEDLINE INDUSTRIES, INC.DRI2021-07-26