FDA.report

S-Monovette®-Needle

Primary DI
04038917005180
Brand
S-Monovette®-Needle
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
85.1440
Catalog number
85.1440
Device description
S-Monovette®-Needle 22Gx1½"
Published
2016-09-16
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

Related Records

Contact Domains

Product Codes

CodeName
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications

CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038917005180PackageGS11000In Commercial Distribution
04038917086653PrimaryGS10
04038917168649Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038917005180040389170051804038917005180
04038917086653040389170866534038917086653
04038917168649040389171686494038917168649

GMDN Terms

TermDefinition
Blood collection needleA sterile, 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 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 however it does not include a blood collection tube holder. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
(800)257-5101customerservice.us@sarstedt.com
+1(800)257-5101customerservice.us@sarstedt.com

Regulatory Flags

DUNS number
388000270
Device count
100
DM exempt
false
Premarket exempt
true
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

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04038917983280S-Monovette® 1.6ml Serum CAT04.2911.00104.2911.0012025-09-25
04038917983310S-Monovette® 1.6ml Serum CAT04.2911.20004.2911.2002025-09-25
04038917983372S-Monovette® 1.6ml LH04.291304.29132025-09-25
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04038917983433S-Monovette® 1.6ml LH04.2913.20004.2913.2002025-09-25
040669160437422.0ml SC Micro Tube protein LB72.694.63072.694.6302025-09-25
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04038917310949Biosphere® screw cap, white65.716.24265.716.2422025-07-25
04038917326698Biosphere® Screw Cap, green65.716.22565.716.2252025-07-25
04038917328289Biosphere® screw cap, orange65.716.22665.716.2262025-07-25
04038917369909Biosphere® Screw Cap, red65.716.22365.716.2232025-07-25
04038917411769Biosphere® screw cap, yellow65.716.21265.716.2122025-07-25
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