FDA.reportPublic FDA data

S-Monovette®-Needle 23Gx1"

Primary DI
04038917530552
Brand
S-Monovette®-Needle 23Gx1"
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
85.1442
Catalog number
85.1442
Published
2025-10-22
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038917530552PrimaryGS10
04038917530569Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917530552040389175305524038917530552
04038917530569040389175305694038917530569

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
04066916046057PCMT 2ML ATC SAF BR 240/BG72.695.05172.695.0512026-10-14
04038917994224Micro tube 0.5ml, PP72.730.30572.730.3052024-09-23
04038917112529tube with screw cap 7ml, 82x13mm, PP60.550.04960.550.0492023-07-22
04038917413008tube with srew cap 5ml, 75x13mm, PP62.504.03962.504.0392023-07-22
04038917080873Push cap, neutral65.10965.1092022-11-30
04038917083492Push cap, neutral65.69765.6972022-11-30
04038917083607Cap with volume limitation65.71065.7102022-11-30
04038917083614Screw cap, neutral65.71265.7122022-11-30
04038917083645Screw cap, neutral65.71665.7162022-11-30
04038917084215Screw cap, neutral65.80565.8052022-11-30
04038917118545Screw cap, blue65.716.00165.716.0012022-11-30
04038917118552Screw cap, yellow65.716.00265.716.0022022-11-30
04038917118569Screw cap, red65.716.00365.716.0032022-11-30
04038917118576Screw cap, pink65.716.00465.716.0042022-11-30
04038917118583Screw cap, green65.716.00565.716.0052022-11-30
04038917118590Screw cap, orange65.716.00665.716.0062022-11-30
04038917118606Screw cap, black65.716.00765.716.0072022-11-30
04038917118613Screw cap, violet65.716.00865.716.0082022-11-30
04038917118620Screw cap, brown65.716.00965.716.0092022-11-30
04038917118675Screw cap, white65.716.02265.716.0222022-11-30

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