Monoject 8881501384

GUDID 50192253035351

1 mL Insulin Syringe Regular Tip

Cardinal Health 200, LLC

Insulin syringe/needle, basic

Primary Device ID	50192253035351
NIH Device Record Key	9e9dc676-3fa5-4f8e-afba-6da58e9af607
Commercial Distribution Status	In Commercial Distribution
Brand Name	Monoject
Version Model Number	8881501384
Catalog Number	8881501384
Company DUNS	961027315
Company Name	Cardinal Health 200, LLC
Device Count	100
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter
Total Volume	1 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10192253035353 [Unit of Use]
GS1	20192253035350 [Primary]
GS1	50192253035351 [Package] Contains: 20192253035350 Package: CASE [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K151949

FDA Product Code

FMF	Syringe, piston

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2023-07-31
Device Publish Date	2023-07-13

On-Brand Devices [Monoject]

50192253034538	1 mL Tuberculin Syringe Luer-Lock Tip
10192253030983	Monoject™ Oral Dose Syringe Unprinted 10 mL
20192253025313	Tuberculin Safety Syringe with Needle
10192253025309	Tuberculin Safety Syringe with Needle
50192253030714	Control Syringe Luer-Lock Tip
20192253030683	Control Syringe Luer-Lock Tip
50192253007150	MONOJECT ENTERAL SYRINGE TIP CAP ENFIT TIP
50192253030943	Curved Tip Syringes
50192253030738	35 mL Pharmacy Tray Luer Lock Tip
50192253030691	3 mL Pharmacy Tray Luer Lock Tip
50192253030837	140 mL Piston Syringe Catheter Tip
50192253034712	60 mL Syringe Catheter Tip
20192253034704	35 mL Syringe Catheter Tip
50192253030967	Monoject 12mL Syringe Luer-Lock Tip
50192253037836	Monoject™, Luer-Slip Syringe, With Special Plunger, 3 mL, Medtronic Part Number 230570
50192253011003	6 mL Clear Oral Syringe
50192253010990	6 mL Amber Oral Syringe
50192253010969	1 mL Clear Oral Syringe
20192253025245	Monoject™ 3 mL Syringe with Hypodermic Safety Needle 25G x 1" (0.5 x 25 mm)
20192253025221	Monoject™ 3 mL Syringe with Hypodermic Safety Needle 23G x 1" (0.6 x 25 mm)
20192253025207	Monoject™ 3 mL Syringe with Hypodermic Safety Needle 22G x 1" (0.7 x 25 mm)
20192253025184	Monoject™ 3 mL Syringe with Hypodermic Safety Needle 21G x 1" (0.8 x 25 mm)
20192253025160	Monoject™ 3 mL Syringe with Hypodermic Safety Needle 20G x 1" (0.9 x 25 mm)
20192253025153	Monoject™ 1 mL Syringe with Hypodermic Safety Needle 30G x ¹/2" (0.3 x 13 mm)
20192253025146	Monoject™ 1 mL Syringe with Hypodermic Safety Needle 27G x ¹/2" (0.4 x 13 mm)
20192253025139	Monoject™ 1 mL Syringe with Hypodermic Safety Needle 25G x 5/8" (0.5 x 16 mm)
50192253010952	1 mL Amber Oral Syringe
20192253025252	3 mL Syringe with Hypodermic Safety Needle
20192253025238	3 mL Syringe with Hypodermic Safety Needle
20192253025214	3 mL Syringe with Hypodermic Safety Needle
20192253025191	3 mL Syringe with Hypodermic Safety Needle
20192253025177	3 mL Syringe with Hypodermic Safety Needle
50192253038710	10 mL Oral Syringe Clear
50192253043653	Sharps Container Chimney Top, Red 14 Quart
50192253003992	Sharps Container Chimney Top, Red 8 Quart
50192253003985	Sharps Container Chimney Top, Red, 4 Quart
20192253034698	35 mL Syringe Luer-Lock Tip
20192253034681	35 mL Syringe Regular Tip
20192253034674	20 mL Syringe Luer-Lock Tip
20192253034667	20 mL Syringe Regular Tip
20192253034605	6 mL Syringe Luer-Lock Tip
20192253034599	6 mL Syringe Regular Tip
20192253033516	3 mL Syringe Luer-Lock Tip
20192253033509	3 mL Syringe Regular Tip
50192253010983	3 mL Oral Syringe Amber
50192253010976	3 mL Oral Syringe Clear
50192253005538	MONOJECT™ GLOVE BOX WITH MOUNTING BRACKET
50192253030950	12 mL Syringe Regular Tip
50192253011010	10 mL Oral Syringe Amber
50192253063408	6 mL Clear Oral Syringe

Trademark Results [Monoject]

Mark Image Registration \| Serial	Company Trademark Application Date
MONOJECT 74560228 2099750 Dead/Cancelled	SHERWOOD SERVICES AG 1994-08-08
MONOJECT 74191238 1762511 Dead/Cancelled	Ecolab Inc. 1991-08-05
MONOJECT 73569258 1403009 Live/Registered	SHERWOOD MEDICAL COMPANY 1985-11-18
MONOJECT 73569236 1403008 Live/Registered	SHERWOOD MEDICAL COMPANY 1985-11-18
MONOJECT 73170520 1124445 Dead/Cancelled	SHERWOOD MEDICAL INDUSTRIES INC. 1978-05-15
MONOJECT 72037194 0664129 Dead/Expired	ROEHR PRODUCTS CO., INC. 1957-09-13