FDA.reportPublic FDA data

MEDLINE

Primary DI
20197344133090
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
SPN311006
Catalog number
SPN311006
Device description
TRIPLE SAFETY PEN NEEDLE, 31G X 6MM
Published
2025-04-05
Public version status
New
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
FMINeedle, hypodermic, single lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20197344133090PackageGS112In Commercial Distribution
00197344133102PrimaryGS10
10197344133093Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2019734413309020197344133090
00197344133102001973441331021973441331020197344133102
1019734413309310197344133093

GMDN Terms#

Term, Definition table
TermDefinition
Autoinjector needleA device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place away from chemical substances.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850033131208RegenKit®-THT-1-URegenlab USA LLCFMI2026-03-23
40888277358455MEDLINEMEDLINE INDUSTRIES, INC.FMI2026-03-19
40888277358462MEDLINEMEDLINE INDUSTRIES, INC.FMI2026-03-19
10050428324070TRUEplusTRIVIDIA HEALTH, INC.FMI2026-03-17
16923033459243EZFINE THIN WALL HYPODERMIC NEEDLEZhejiang Kindly Medical Devices Co., Ltd.FMI2026-03-10
00850056748568FORWARD® Intraosseous Infusion BundleINTEGRATED MEDCRAFT LLCFMI2026-03-02
10850060997980CerosRhino Medical Supply IncFMI2026-02-23
08800062763736SHARP NEEDLES, DermiSyncYONG CHANG CorporationFMI2026-02-23
10857273002470Clickfine® pen needlesHTL STREFA S AFMI2026-02-17
10857273002487Clickfine® pen needlesHTL STREFA S AFMI2026-02-17
10857273002548Clickfine® pen needlesHTL STREFA S AFMI2026-02-17
10857273002555Clickfine® pen needlesHTL STREFA S AFMI2026-02-17
50192253037119MonojectCardinal Health 200, LLCFMI2026-02-17
20850083784052Comfort EZS.D.I. USA, INC.FMI2026-02-13
20850083784175Comfort EZS.D.I. USA, INC.FMI2026-02-13
04046955143184Omnican® fineB. Braun Melsungen AktiengesellschaftFMI2026-02-10
04046961013068Omnican® fineB. Braun Melsungen AktiengesellschaftFMI2026-02-10
50192253037010MonojectCardinal Health 200, LLCFMI2026-02-10
50192253037058MonojectCardinal Health 200, LLCFMI2026-02-10
50192253037096MonojectCardinal Health 200, LLCFMI2026-02-10
50192253037164MonojectCardinal Health 200, LLCFMI2026-02-10
50192253037171MonojectCardinal Health 200, LLCFMI2026-02-10
50192253037218MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038154MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038161MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038178MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038185MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038192MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038208MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038215MonojectCardinal Health 200, LLCFMI2026-02-10