Glucertain

Primary DI
00850005565659
Brand
Glucertain
Company
CELLERA LLC
Model
30505
Catalog number
30505
Device description
"Insulin Safety Syringes 0.5 ml 29 G x 1/2"", 100/box, 5 boxes/case"
Published
2023-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K150758000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150758000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005565666PackageGS1100In Commercial Distribution
00850005565673PackageGS15In Commercial Distribution
00850005565659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005565666008500055656668500055656660850005565666
00850005565673008500055656738500055656730850005565673
00850005565659008500055656598500055656590850005565659

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.

Contacts#

Phone, Email table
PhoneEmail
800-892-2391sales@cellerallc.com

Regulatory Flags#

DUNS number
960091929
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850065122236Vitale22020220202026-10-01
00850031608146Vitale STRONG20656206562023-02-15
B492301500Glucertain30150301502017-06-07
00850065122090Vitale23077230772026-02-24
00850065122076Vitale 24408244082025-07-17
00850065122083Vitale 24408244082025-07-17
00850005565185Vitale22000220002019-05-24
00850005565376Vitale22011220112020-04-20
00850005565406Vitale22022220222020-04-20
00850005565420Vitale22044220442020-04-20
00850005565444Vitale22077220772020-04-20
00850031608559Vitale22088220882023-02-15
00850065122014Vitale22010220102025-04-11
00850005565901Vitale24203242032021-10-31
00850005565932Vitale24204242042021-11-02
00850005565956Vitale24206242062023-02-15
00850005565970Vitale24207242072023-02-15
00850031608054Vitale24209242092023-02-15
00850031608573Vitale 24406244062023-02-01
00850031608597Vitale 24410244102023-02-01

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Primary DI, Brand, Company table
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09347144016216Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
20612479288496McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
20612479288526McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
10304040193843Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
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