FDA.report

NAMIC

Primary DI
10193489067170
Brand
NAMIC
Company
MEDLINE INDUSTRIES, INC.
Model
80601006
Catalog number
80601006
Device description
MTO PERC MP 2V 200S RH ON BARD PG
Published
2021-05-12
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

Product Codes

CodeName
DRSTransducer, blood-pressure, extravascular

Product Code Classifications

CodeDeviceSpecialtyClass
DRSTransducer, Blood-Pressure, ExtravascularCardiovascular2

Premarket Submissions

SubmissionSupplement
K902472000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K902472000MORSE DT MANIFOLDNorth American Instrument Corp.1990-08-23DRS

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489067177PrimaryGS10
10193489067170Unit of UseGS10

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
25
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
false
Sterilization required before use
true

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