FDA.report

NAMIC

Primary DI
20193489064954
Brand
NAMIC
Company
MEDLINE INDUSTRIES, INC.
Model
70038108
Catalog number
70038108
Device description
MANIFOLD ASM 1V RH/ON PERC. PG
Published
2024-08-06
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
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
20193489064954PackageGS110In Commercial Distribution
10193489064957PrimaryGS10

GMDN Terms

TermDefinition
Invasive-pressure external transducer, single-useA sterile, noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and transmit them as electrical signals to an appropriate monitoring device. It consists of a pressure transducer and a connection cable and may be designed to be used with a pressure transducer dome. 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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