FDA.report

MedStream

Primary DI
10842472102007
Brand
MedStream
Company
MEDICAL SPECIALTIES DISTRIBUTORS, LLC
Model
MSDC-C18297
Catalog number
MSDC-C18297
Device description
CUSTOM DRESSING CHANGE KIT
Published
2016-09-22
Public version status
Update
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

Contact Domains

Product Codes

CodeName
OXQDressing Change Tray

Product Code Classifications

CodeDeviceSpecialtyClass
OXQDressing Change TrayGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10842472102007PackageGS124In Commercial Distribution
00842472102000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084247210200710842472102007
00842472102000008424721020008424721020000842472102000

GMDN Terms

TermDefinition
Arterial/central venous catheterization support/maintenance kitA collection of sterile devices intended to support the catheterization procedure of an artery and/or central vein (large veins of the upper body), and/or to provide ongoing vascular catheter maintenance. It is primarily intended to be used at the patient’s bedside and includes devices intended to support catheter placement and/or or ongoing maintenance (e.g., dressing change, catheter flushing) such as: disposable drapes, disinfectant wipes, dressings, gown, tourniquets, ultrasound system transducer cover, coupling gel, sharps container, syringe, and saline solution; neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
800-967-6400customerservice@msdistributors.com

Regulatory Flags

DUNS number
153608369
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
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

Other Devices From This Company

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00842472106992MedStreamMSCLEO24MSCLEO242020-02-28
10842472107002MedStreamMSCLEO31MSCLEO312020-02-28
00842472107012MedStreamMSCLEO42MSCLEO422020-02-28
10842472107026MedStreamMSCLEO6MSCLEO62020-02-28
10842472107033MedStreamMSCLEO9MSCLEO92020-02-28
10842472107101MedStreamMSDC-C03765MSDC-C037652019-07-26
10842472107118MedStreamMSDC-003625MSDC-0036252019-08-16
10842472107095MedStreamMSDC-C23361MSDC-C233612019-06-28
10842472107064MedStreamMSDC-023346MSDC-0233462019-05-22
10842472107071MedStreamMSDC-023347MSDC-0233472019-05-22
10842472100669MedStreamMS703PMS703P2016-09-23
10842472100676MedStreamMS711PMS711P2016-09-23
10842472100683MedStreamMS720PMS720P2016-09-23
10842472100713MedStreamMS916MS9162016-09-23
10842472100720MedStreamMS920MS9202016-09-23
10842472100959MedStreamMSDC-072484MSDC-0724842016-09-23
10842472100966MedStreamMSIV-J8023AMSIV-J8023A2016-11-15
00842472100976MedStreamMSCS-014764MSCS-0147642016-09-20

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