ACCEL® 612138
GUDID 04046955237500
3 PC INT, 018X60 NIT-GOLD, 21GA TROC
B BRAUN INTERVENTIONAL SYSTEMS, INC
Vascular catheter introduction set, nonimplantable| Primary Device ID | 04046955237500 |
| NIH Device Record Key | e1a004ff-7893-4fde-99fe-bdb6fcd119b5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACCEL® |
| Version Model Number | 612138 |
| Catalog Number | 612138 |
| Company DUNS | 784259751 |
| Company Name | B BRAUN INTERVENTIONAL SYSTEMS, INC |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 |
Customer Support Contacts
Device Dimensions
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Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04046955237494 [Unit of Use] |
| GS1 | 04046955237500 [Primary] |
FDA Product Code
| OFL | Percutaneous sheath introducer kit |
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 | 2019-06-07 |
| Device Publish Date | 2019-04-26 |
On-Brand Devices [ACCEL®]
| 04046955323494 | 600ML DRAI.BOTTLE,DR600LOCK,PVC-FREE,FPS |
| 04046955237647 | 3 PC INT, 21GAX15CM TROCAR |
| 04046955237623 | 3 PC INT, 22GAX15CM CHIBA |
| 04046955237609 | 3 PC INT, 018X60 SS-GOLD, 22GA CHIBA |
| 04046955237586 | 3 PC INT, 018X60 NIT-GOLD, 22GA CHIBA |
| 04046955237562 | 3 PC INT, 018X60 SS-GOLD, 21GA TROC |
| 04046955237548 | 3 PC, 018X60 NIT-GOLD, 038 GW, 21GA TROC |
| 04046955237524 | 3 PC, 018X60 SS-GOLD, 038 GW, 21GA TROC |
| 04046955237500 | 3 PC INT, 018X60 NIT-GOLD, 21GA TROC |
| 04046955237487 | HYDROPHILIC 6F 3 PIECE INTRODUCER |
| 04046955237388 | 22GA X 20CM CHIBA NEEDLE |
| 04046955237364 | 22GA X 15CM CHIBA NEEDLE |
| 04046955237340 | 21GA X 15CM TROCAR NEEDLE |
| 04046955639304 | ACCEL SECUREMENT DEVICE 12-18F |
| 04046955639281 | ACCEL SECUREMENT DEVICE 5-12F |
| 04046955639205 | ACCEL UNIVERSAL J-CURVED PD 12F 25CM |
| 04046955639182 | ACCEL UNIVERSAL J-CURVED PD 10F 25CM |
| 04046955639168 | ACCEL UNIVERSAL J-CURVED PD 8F 25CM |
| 04046955639144 | ACCEL CURVED J-TYPE PD 6F 20CM |
| 04046955639120 | ACCEL BILLIARY PD 14F 40CM W/MB AND LOCK |
| 04046955639106 | ACCEL BILLIARY PD 12F 40CM W/MB AND LOCK |
| 04046955639083 | ACCEL BILLIARY PD 10F 40CM W/MB AND LOCK |
| 04046955639069 | ACCEL BILLIARY PD 8F 40CM W/MB AND LOCK |
| 04046955639045 | ACCEL MINICLOSED LOOP PD 14F 25CM W/LOCK |
| 04046955639021 | ACCEL MINICLOSED LOOP PD 12F 25CM W/LOCK |
| 04046955639007 | ACCEL MINICLOSED LOOP PD 10F 25CM W/LOCK |
| 04046955638987 | ACCEL MINICLOSED LOOP PD 8F 25CM W/ LOCK |
| 04046955638963 | ACCEL MINICLOSED LOOP PD 7F 25CM W/LOCK |
| 04046955638949 | ACCEL MINICLOSED LOOP PD 12F 15CM W/LOCK |
| 04046955638925 | ACCEL MINICLOSED LOOP PD 10F 15CM W/LOCK |
| 04046955638901 | ACCEL MINICLOSED LOOP PD 8F 15CM W/ LOCK |
| 04046955638888 | ACCEL MINICLOSED LOOP PD 6F 15CM W/ LOCK |
| 04046955638864 | ACCEL MINICLOSED LOOP PD 7F 15CM |
| 04046955638840 | ACCEL MINICLOSED LOOP PD 6F 15CM |
| 04046955638826 | ACCEL MINICLOSED LOOP PD 5F 15CM |
| 04046955638802 | ACCEL APD 14F 40CM W/ MB AND LOCK |
| 04046955638789 | ACCEL APD 12F 40CM W/ MB AND LOCK |
| 04046955638765 | ACCEL APD 10F 40CM W/ MB AND LOCK |
| 04046955638741 | ACCEL APD 8F 40CM W/ MB AND LOCK |
| 04046955638727 | ACCEL APD 14F 35CM W/ LOCK |
| 04046955638703 | ACCEL APD 12F 35CM W/ LOCK |
| 04046955638680 | ACCEL APD 10F 35CM W/ LOCK |
| 04046955638666 | ACCEL APD 8F 35CM W/ LOCK |
| 04046955638642 | ACCEL APD 14F 25CM W/ MB AND LOCK |
| 04046955638628 | ACCEL APD 12F 25CM W/ MB AND LOCK |
| 04046955638604 | ACCEL APD 10F 25CM W/ MB AND LOCK |
| 04046955638581 | ACCEL APD 8F 25CM W/ MB AND LOCK |
| 04046955638567 | ACCEL APD 16F 25CM W/ LOCK |
| 04046955638543 | ACCEL APD 14F 25CM W/ LOCK |
| 04046955638529 | ACCEL APD 12F 25CM W/ LOCK |
Trademark Results [ACCEL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCEL 98858358 not registered Live/Pending |
Do Outdoors, LLC 2024-11-18 |
 ACCEL 98807022 not registered Live/Pending |
Vornado Air LLC 2024-10-17 |
 ACCEL 98462604 not registered Live/Pending |
Valent BioSciences LLC 2024-03-22 |
 ACCEL 98280621 not registered Live/Pending |
Xyphos Biosciences, Inc. 2023-11-21 |
 ACCEL 97899029 not registered Live/Pending |
Totus Medicines Inc. 2023-04-20 |
 ACCEL 97872281 not registered Live/Pending |
Warren Distribution LLC 2023-04-04 |
 ACCEL 97636904 not registered Live/Pending |
Accel Holdings L.L.C. 2022-10-18 |
 ACCEL 97067871 not registered Live/Pending |
ACCEL Performance Group LLC 2021-10-11 |
 ACCEL 90711704 not registered Live/Pending |
Hemostasis, LLC 2021-05-14 |
 ACCEL 90612962 not registered Live/Pending |
Impact Biosystems, Inc. 2021-03-30 |
 ACCEL 90067974 not registered Live/Pending |
Accel Practice, LLC 2020-07-22 |
 ACCEL 88793301 not registered Live/Pending |
ACCEL 2020-02-11 |
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