FDA.reportPublic FDA data

GoodSense Comfort Assist Insulin Syringes

Primary DI
10370030128737
Brand
GoodSense Comfort Assist Insulin Syringes
Company
L PERRIGO COMPANY
Model
053108
Device description
.5cc 8mm 31G Insulin Syringe, Sterile, Single-Use, 100ct
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062702000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062702000ULTICARE DISPOSABLE SYRINGES AND NEEDLESUltimed, Inc.2006-11-29FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10370030128737PackageGS130Not in Commercial Distribution
00370030128730PrimaryGS10
10070030510739Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1037003012873710370030128737
00370030128730003700301287303700301287300370030128730
1007003051073910070030510739

GMDN Terms#

Term, Definition table
TermDefinition
Insulin syringe/needle, basicA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006013346
Device count
100
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00070030147655Good Sense7W926C2C12022-10-11
00070030511739SCARAWAY SILICONE GEL 20G11A3QSAC12021-03-17
00070030165536SCARAWAY SILICONE GEL 20G11A3QSAC12021-03-17
00070030510718Comfort Assist Insulin Syringe1030082016-09-24
00070030510725Comfort Assist Insulin Syringe0331082016-09-24
00070030510732Comfort Assist Insulin Syringe0531082016-09-24
00070030510749Comfort Assist Insulin Syringe1029122016-09-24
00070030510756Comfort Assist Insulin Syringe0330082016-09-24
00070030510763Comfort Assist Insulin Syringe0530082016-09-24
00070030510770Comfort Assist Insulin Syringe1031082016-09-24
00370030128709GoodSense Comfort Assist Insulin Syringes0529122016-09-24
00370030128716GoodSense Comfort Assist Insulin Syringes1030082016-09-24
00370030128723GoodSense Comfort Assist Insulin Syringes0331082016-09-24
00370030128730GoodSense Comfort Assist Insulin Syringes0531082016-09-24
00370030128747GoodSense Comfort Assist Insulin Syringes0330082016-09-24
00370030128754GoodSense Comfort Assist Insulin Syringes0530082016-09-24
00370030128761GoodSense Comfort Assist Insulin Syringes1031082016-09-24
10370030128706GoodSense Comfort Assist Insulin Syringes0529122016-09-24
10370030128713GoodSense Comfort Assist Insulin Syringes1030082016-09-24
10370030128720GoodSense Comfort Assist Insulin Syringes0331082016-09-24

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Primary DI, Brand, Company table
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10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
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