FDA.reportPublic FDA data

S-Monovette®

Primary DI
04038917228299
Brand
S-Monovette®
Company
SARSTEDT, INC.
Model
01.1624.001
Catalog number
01.1624.001
Device description
S-Monovette® 8.8 ml ACD-A
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK0700290

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0700290

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038917228299PackageGS1500In Commercial Distribution
04038917228305PrimaryGS10
04038917228312Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917228299040389172282994038917228299
04038917228305040389172283054038917228305
04038917228312040389172283124038917228312

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, acid citrate dextrose A (ACD-A)A sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the blood anticoagulant acid citrate dextrose A (ACD-A). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation [e.g., blood grouping, human leukocyte antigen (HLA) phenotyping and deoxyribonucleic acid (DNA) testing]. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-257-5101customerservice.us@sarstedt.com
+1(800)257-5101customerservice.us@sarstedt.com

Regulatory Flags#

DUNS number
035410179
Device count
50
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038917398763S-Monovette® POC Collect Kit51.5100.10051.5100.1002017-07-28
04038917087841Tissue Culture Coverslip 25 mm83.18402022-11-22
04038917134040Tissue Culture Coverslip 22 mm83.1840.0012022-11-22
04038917134057Tissue Culture Coverslip 13 mm83.1840.0022022-11-22
04038917398220"Tourniquet Single Use NL Flat, 1"""95.1007.1012023-06-06
04038917554633Screw Cap Tube 101x16 RBS with saline51.540.3872022-12-04
04038917554671Screw Cap Tube 82x13 FB with saline51.550.1232022-12-04
04038917952569Screw Cap Tube 79x16 RB with saline51.506.3902022-12-04
04038917554640Screw Cap Tube 101x16 RBS with saline51.540.3872022-12-04
04038917554688Screw Cap Tube 82x13 FB with saline51.550.1232022-12-04
04038917952552Screw Cap Tube 79x16 RB with saline51.506.3902022-12-04
04038917033435Screw Cap Tube 120x17 mm, 15 ml, PS62.553.0022022-11-22
04038917033442Screw Cap Tube 120x17 mm, 15 ml, PS62.553.2052022-11-22
04038917033497Screw Cap Tube 120x17 mm, 15 ml, PP62.554.2052022-11-22
04038917075671Urine Monovette®, 10ML with luerlock10.252.0282022-11-22
04038917376334Screw Cap Tube 120x17 mm, 15 ml, PP62.554.1002022-11-22
04038917112949Screw Cap Tube 120x17 mm, 15 ml, PS62.553.0022022-11-22
04038917112987Screw Cap Tube 120x17 mm, 15 ml, PS62.553.2052022-11-22
04038917113144Screw Cap Tube 120x17 mm, 15 ml, PP62.554.2052022-11-22
04038917104494Urine Monovette®, 10ML with luerlock10.252.0282022-11-22

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