FDA.reportPublic FDA data

JJ CARE

Primary DI
05060988910062
Brand
JJ CARE
Company
Jack Jack LLC
Model
JJ033112P-60
Device description
"Insulin syringe U-100, 0.3cc/ml 31G 1/2"" JJ CARE Insulin syringes are disposable and meant for one-time use. "
Published
2023-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

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
K152808000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152808000U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd.2016-03-25MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060988910069Direct MarkingGS10
25060988910066PackageGS1150In Commercial Distribution
05060988910062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506098891006915060988910069
2506098891006625060988910066
05060988910062050609889100625060988910062

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
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The products should be stored in a dry, well-ventilated room, keep away from any corrosive gas.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8334201183thefalene@jackjackllc.com

Regulatory Flags#

DUNS number
052514128
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060988910079JJ CAREJJ033112P-1002023-07-15
05060988910086JJ CAREJJ102912-1202023-07-15
05060988910093JJ CAREJJ102912-302023-07-15
05060988910109JJ CAREJJ103012-1002023-07-15
05060988910116JJ CAREJJ103012-302023-07-15
05060988910123JJ CAREJJ103108-1002023-07-15
05060988910130JJ CAREJJ103108-1002023-07-15
05060988910147JJ CAREJJ103108-302023-07-15
05060988910154JJ CAREJJ053108-1002023-07-15
05060988910161JJ CAREJJ033108-1002023-07-15
15060988910045JJ CARE300232023-07-15
15060988910007JJ CAREHH-X-T, IC2023-03-15
15060988910014JJ CAREKFT-092023-03-15
15060988910021JJ CAREKFT-032023-03-15
15060988910038JJ CAREHH-X-T2023-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
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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