FDA.reportPublic FDA data

SYRINGE RETRACT U100 1cc 29x.5

Primary DI
00369771003109
Brand
SYRINGE RETRACT U100 1cc 29x.5
Company
GERI-GENTLE CORPORATION
Model
11-444
Device description
SYRINGE RETRACT U100 1cc 29x.5
Published
2023-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston
MEGSyringe, Antistick

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
MEGSyringe, AntistickGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210216000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210216000Disposable Automatically Retractable Insulin Safety SyringeShantou Wealy Medical Instrument Co.,Ltd2022-03-04MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00369771003123PackageGS1100In Commercial Distribution
00369771003109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00369771003123003697710031233697710031230369771003123
00369771003109003697710031093697710031090369771003109

GMDN Terms#

Term, Definition table
TermDefinition
ENFit oral/enteral syringe, single-useA manual device intended to be used for the administration of oral medication or delivery of enteral nutrition by connection to an enteral administration device. It consists of a calibrated hollow barrel (cylinder) and a moveable plunger intended to be operated by a healthcare provider or parent device. The tip is designed to mate only with enteral administration devices (i.e., ENFit) and is incompatible with Luer connectors; the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a single-use device.

Regulatory Flags#

DUNS number
361663839
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10369771000891Syringes Safety114662019-06-01
10369771000907Syringes Safety114672019-06-01
00369771000832Syringes Safety114662022-05-01
00369771001815NEEDLES 23x111-2312021-01-01
00369771001846NEEDLES 25x111-2512021-01-01
00369771001877NEEDLES 25x5/811-25582021-01-01
00369771001785Syringe 3ml11-3002021-01-01
00369771001525HMEF w/ Flextube19-HMEF1002020-06-01
00369771003642Sharps Collector 5QT111382023-11-01
00369771003659Sharps Collector 5QT111382023-11-01
00369771003420Prefilled Syrings11-10102023-09-01
00369771003390Pen Needle11-3052023-09-01
00369771003437Prefilled Syrings11-10102023-09-01
10369771000785Lancets Safety25-4572023-08-01
00369771003161Oxygen Concentrator19-50002023-08-01
20369771000782Lancets Safety25-4572023-08-01
00369771001273Gloves120972019-09-01
00369771001365Gloves122902019-09-01
00369771001389Gloves122912019-09-01
00369771001402Gloves12-3092019-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391530753944Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753524Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753531Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753548Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753555Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753562Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753579Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753593Polycarbonate syringe -DMC MEDICAL LIMITEDFMF2026-06-01
05391530753609Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753616Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753623Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753647Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753654Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753661Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753678Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01