FDA.reportPublic FDA data

MedStream

Primary DI
00842472100846
Brand
MedStream
Company
MEDICAL SPECIALTIES DISTRIBUTORS, LLC
Model
MS994
Catalog number
MS994
Device description
VIAL ADAPTER CLAVE® CONNECTOR MULTIDOSE
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
K081361000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081361000CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXXIcu Medical, Inc.2008-08-28FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10842472100843PackageGS150Not in Commercial Distribution
00842472100846PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084247210084310842472100843
00842472100846008424721008468424721008460842472100846

GMDN Terms#

Term, Definition table
TermDefinition
Breath specimen container IVDA container (e.g., bag, tube, collection card) intended to contain a specimen of air exhaled from a patient for subsequent in vitro determination of chemical and/or biological markers (e.g., volatile organic compounds) in the specimen to aid metabolic profiling or the diagnosis of disorders [e.g., lipid peroxidation levels, gastrointestinal H. pylori infection, coronavirus disease (COVID-19) infection]. It typically consists of carbon dioxide (CO2) absorbing material which may be encased within the container, a port/mouthpiece or an access device (e.g., tubing) to facilitate specimen collection, and/or an adaptor for connection to an analyser. 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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Primary DI, Brand, Company table
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