FDA.reportPublic FDA data

MedStream

Primary DI
10842472100843
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
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10842472100843PackageGS150In 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
Vial transfer spikeA sterile device designed to be securely attached to the septum end of a vial to create a channel, by spiking through the vial?s sealed stopper, to allow access to the contents of the vial. This device is intended to reduce risk of unwanted exposure to the vial?s contents (e.g., liquid medication) by providing a sterile pathway between the vial and a recipient receptacle/device for subsequent delivery to a patient. It typically consists of polyvinyl chloride (PVC) screw cap with an internal spike and an external connector. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
153608369
Device count
1
DM exempt
true
Premarket exempt
false
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#

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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08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840006535VYGONVygon CorporationFPA2020-03-12
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-12-13
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