Dart 21-001
GUDID M68921001010
14GA 3.25" Needle with Catheter for Chest Decompression
Safeguard US Operating, LLC
Pleural catheter| Primary Device ID | M68921001010 |
| NIH Device Record Key | 1d705dd3-e5d6-42ed-a6f6-1c48f3c25b58 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dart |
| Version Model Number | 01 |
| Catalog Number | 21-001 |
| Company DUNS | 118492643 |
| Company Name | Safeguard US Operating, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M68921001010 [Primary] |
FDA Product Code
| GCB | Needle, Catheter |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
[M68921001010]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-04-12 |
| Device Publish Date | 2018-12-20 |
Devices Manufactured by Safeguard US Operating, LLC
| M68985201020 - Mojo Vehicle Rescue Bag - Basic | 2026-02-09 This device is apart of the Mojo Aid and Litter Systems. It is a minimal cube and weight solutions intended to be vehicle born |
| M6898810301020 - Pocket Trauma Kit Basic | 2026-02-09 First Responder kits are intended to be carried and used by dedicated non-medical First Responders. Vacuum-seal trauma treatmen |
| M6898810304020 - Pocket Trauma Kit | 2026-02-09 First Responder kits are intended to be carried and used by dedicated non-medical First Responders. Vacuum-seal trauma treatmen |
| M68980820120 - Valkyrie LTOWB Collection Set | 2026-01-30 This convenience kit is intended to be used by trained and credentialed individuals to treat blood loss or to supply blood due t |
| M68980821110 - Valkyrie LTOWB Administration Set | 2026-01-30 This convenience kit is intended to be used by trained and credentialed individuals to treat blood loss or to supply blood due t |
| M68980820110 - Valkyrie LTOWB Collection Set | 2026-01-23 ADVANCED LTOWB COLLECTION SET Constricting Band (18" x 1") 1 ea Gauze Sponge 2 ea Safety IV Ca |
| M68980821100 - Valkyrie LTOWB Administration Set | 2026-01-23 ADVANCED LTOWB ADMINISTRATION SET Constricting Band (18" x 1") 1 ea Gauze Sponge 4 ea Safe |
| M6895930010040 - HAWK Warming Grid | 2026-01-12 HAWK WARMING Grid 10 ea 23" x 20" HAWK Warming Grid with absorbent pad Warning: Not for use on infants. Do not separate the HA |
Trademark Results [Dart]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DART 98780771 not registered Live/Pending |
Sheltered Wings, Inc. 2024-10-01 |
 DART 98780759 not registered Live/Pending |
Sheltered Wings, Inc. 2024-10-01 |
 DART 98563952 not registered Live/Pending |
SC Autosports, LLC 2024-05-22 |
 DART 98540886 not registered Live/Pending |
Dext Capital, LLC 2024-05-08 |
 DART 98378279 not registered Live/Pending |
Bosma, Marinus Bernard 2024-01-26 |
 DART 98299269 not registered Live/Pending |
CamelBak Products, LLC 2023-12-05 |
 DART 97847018 not registered Live/Pending |
Alcor Life Extension Foundation 2023-03-20 |
 DART 97712938 not registered Live/Pending |
Dart Container Corporation 2022-12-12 |
 DART 97627815 not registered Live/Pending |
ALKON CORPORATION 2022-10-11 |
 DART 97306940 not registered Live/Pending |
DART CONSULTING AND TRAINING PTE. LTD. 2022-03-11 |
 DART 97202198 not registered Live/Pending |
INVENTEL.TV LLC 2022-01-04 |
 DART 97202196 not registered Live/Pending |
INVENTEL.TV LLC 2022-01-04 |
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