Monoject 8881053105
GUDID 50885380194069
Monoject Standard Pen Needle Universal Fit 31G (0.25mm) x 5mm
Cardinal Health 200, LLC
Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle| Primary Device ID | 50885380194069 |
| NIH Device Record Key | 00506d85-f5c3-4cab-837c-a0e15948c18a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Monoject |
| Version Model Number | 8881053105 |
| Catalog Number | 8881053105 |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | true |
Device Dimensions
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10885380194061 [Unit of Use] |
| GS1 | 20885380194068 [Primary] |
| GS1 | 50885380194069 [Package] Contains: 20885380194068 Package: CASE [24 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170846
FDA Product Code
| FMI | Needle, hypodermic, single lumen |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-25 |
| Device Publish Date | 2023-09-15 |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.