FDA.reportPublic FDA data

Safety-Multifly®-Needle

Primary DI
04038917423892
Brand
Safety-Multifly®-Needle
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
85.1638.201
Catalog number
85.1638.201
Device description
Safety-Multifly® 21G tube 240mm
Published
2019-12-13
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
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038917423892PrimaryGS10
04038917235297Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917423892040389174238924038917423892
04038917235297040389172352974038917235297

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, invasiveA collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. 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
120
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
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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Primary DI, Brand, Company table
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B098AMS188520Aligned Medical SolutionsAligned Medical SolutionsJKA2026-10-12
10885403520631BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-09
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10612479285993McKessonMCKESSON MEDICAL-SURGICAL INC.FPA2026-10-06
10612479286013McKessonMCKESSON MEDICAL-SURGICAL INC.FPA2026-10-06
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00884450707104Merit Medical®Merit Medical Systems, Inc.FPA2026-09-26
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04046955114559IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-19
00859776006033K-QUE-SAR-SHIPPERQuest DiagnosticsJKA2026-09-15
10850083986008TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986015TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986022TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986039TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10813153027339CodanCodan US CorporationFPA2026-07-31
10813153028312CodanCodan US CorporationFPA2026-07-31
10850048235196HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
10850048235264HMG IV Administration SetHartman Medical Group LLCFPA2026-07-31
20850048235193HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31