FDA.reportPublic FDA data

S-Monovette®-Needle

Primary DI
04038917085519
Brand
S-Monovette®-Needle
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
85.1160
Catalog number
85.1160
Device description
S-Monovette®-Needle 20G
Published
2016-09-16
Public version status
Update
Distribution status
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
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038917004169PackageGS11000In Commercial Distribution
04038917085519PrimaryGS10
04038917167604Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917004169040389170041694038917004169
04038917085519040389170855194038917085519
04038917167604040389171676044038917167604

GMDN Terms#

Term, Definition table
TermDefinition
Non-fixed blood collection needleA sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient; it does not include wings for fixation/placement (i.e., not a venous butterfly/scalp vein needle). It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike and/or a safety cover; however, it does not include blood collection tubing or a tube holder (i.e., not a set). This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
388000270
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038917927048Sediplus® S 2000 NX90.109290.10922026-07-22
04038917124614TUBE SEGMENT OPENER ASM TB 75/12 PS95.1000.47695.1000.4762026-07-21
04038917124935ESR RACK N/BACK PANEL90.1060.06290.1060.0622026-07-21
04038917390835TUBE SEGMENT OPENER ASM TB 75/ 12 PS CB95.1000.47795.1000.4772026-07-21
04038917581882Salivette®51.1534.10051.1534.1002026-07-21
04066916053802Tube 3.5ml, 92x13 (round), PP62.617.00162.617.0012026-07-21
04066916055837Screw cap, pastel-green65.716.04565.716.0452026-07-21
04066916055998Screw cap, pastel-orange65.716.04665.716.0462026-07-21
04066916056049Screw cap, pastel-violet65.716.04865.716.0482026-07-21
04066916056148Screw cap, pastel-yellow65.716.04265.716.0422026-07-21
04066916056407Screw cap, pastel-blue65.716.04165.716.0412026-07-21
04066916057831SafeSeal tube 0.5ml72.704.05072.704.0502026-07-21
04066916057879SafeSeal tube 0.5ml, brown72.704.05172.704.0512026-07-21
04066916058012SafeSeal tube 0.5ml, red72.704.05272.704.0522026-07-21
04066916058050SafeSeal tube 0.5ml, yellow72.704.05472.704.0542026-07-21
04066916058135SafeSeal tube 0.5ml, green72.704.05572.704.0552026-07-21
04066916058173SafeSeal tube 0.5ml, blue72.704.05672.704.0562026-07-21
04066916058210Micro tube 0.5ml SafeSeal72.704.45072.704.4502026-07-21
04066916058296SafeSeal tube 1.5ml72.706.05072.706.0502026-07-21
04066916058340SafeSeal tube 1.5ml, brown72.706.05172.706.0512026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30382903679929BD Vacutainer® SST™ Blood Collection TubeBECTON, DICKINSON AND COMPANYJKA2026-07-20
10197344112722MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216116MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216130MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216147MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216154MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216161MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216178MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216185MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
00850048720343C-QuestLifeOutcomes LLCJKA2026-07-14
00850048720466C-QuestLifeOutcomes LLCJKA2026-07-14
00850048720558C-QuestLifeOutcomes LLCJKA2026-07-14
00850048720237C-QuestLifeOutcomes LLCJKA2026-07-09
50192253051153CARDINAL HEALTHCardinal Health 200, LLCJKA2026-06-25
00199536930506BluelineTransparent Supply Solutions Ltd.JKA2026-06-05
00199536930513BluelineTransparent Supply Solutions Ltd.JKA2026-06-05
08887629000008BUHNSP TECH PTE LTDJKA2026-05-29
08887629000053BUCANSP TECH PTE LTDJKA2026-05-29
08887629000060BTANSP TECH PTE LTDJKA2026-05-29
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044809CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044816CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044823CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044878CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
10197344019649MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-04-23