FDA.reportPublic FDA data

MedStream

Primary DI
00842472100501
Brand
MedStream
Company
MEDICAL SPECIALTIES DISTRIBUTORS, LLC
Model
MS407
Catalog number
MS407
Device description
ULTRA MB 60IN EXT SET LL,SLD CLMP,APV.38
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964435000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964435000PRIMARY IV SETIcu Medical, Inc.1997-04-02FMG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10842472100508PackageGS150Not in Commercial Distribution
00842472100501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084247210050810842472100508
00842472100501008424721005018424721005010842472100501

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
800-967-6400customerservice@msdistributors.com

Regulatory Flags#

DUNS number
153608369
Device count
1
DM exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842472100952MedStreamMSDC-072484MSDC-0724842016-09-23
00842472100969MedStreamMSIV-J8023AMSIV-J8023A2016-11-15
00842472100990MedStreamMSD800302MSD8003022016-09-20
00842472101003MedStreamMSD800303MSD8003032016-09-20
00842472101010MedStreamMSD800510MSD8005102016-09-20
00842472101027MedStreamMSD800515MSD8005152016-09-20
00842472101034MedStreamMSDC-008537MSDC-0085372016-09-20
00842472101041MedStreamMSDC-008552MSDC-0085522016-09-20
00842472101065MedStreamMSDC-008839MSDC-0088392016-09-20
00842472101072MedStreamMSDC-009720MSDC-0097202016-09-20
00842472101089MedStreamMSDC-009963MSDC-0099632016-09-20
00842472101096MedStreamMSDC-010053MSDC-0100532016-09-20
00842472101102MedStreamMSDC-010205MSDC-0102052016-09-20
00842472101126MedStreamMSDC-010956MSDC-0109562016-09-20
00842472101133MedStreamMSDC-010964MSDC-0109642016-09-20
00842472101140MedStreamMSDC-011198MSDC-0111982016-09-20
00842472101157MedStreamMSDC-011337MSDC-0113372016-09-20
00842472101164MedStreamMSDC-011709MSDC-0117092016-09-20
00842472101171MedStreamMSDC-011767MSDC-0117672016-09-20
00842472101188MedStreamMSDC-011963MSDC-0119632016-09-20

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