Curaplex

GUDID 00815277025379

Curaplex Bag Valve Mask (BVM), Pediatric, incl Mask, Oxygen Reservoir, 7 ft Tubing 12ea/cs

BOUND TREE MEDICAL, LLC

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 00815277025379
• NIH Device Record Key: 1c23859a-0da7-46cf-b2cc-081dbd07def9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Curaplex
• Version Model Number: 30071
• Company DUNS: 070556204
• Company Name: BOUND TREE MEDICAL, LLC
• Device Count: 1
• 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: true
• 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: 450 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815277025362 [Primary]
GS1	00815277025379 [Package]; Contains: 00815277025362; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053466

FDA Product Code

• BTM: Ventilator, emergency, manual (resuscitator)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-14

On-Brand Devices [Curaplex]

• 00812277034134: Curaplex XPS Fitted Stretcher Sheet, 36 x 90, Fluid Resist
• 00812277034127: Curaplex Stop the Bleed, Advance Kit
• 00812277034110: Curaplex Stop the Bleed, Basic Kit
• 00812277033984: Curaplex Tactical Intubation Pouch Miller 2 Only Fiber Optic
• 00812277033977: *Custom* HFD IFAK Kit
• 00812277033960: *Custom* Dayton Children's Hospital First Aid Kit
• 00812277033939: *Custom* LMPD PPE Kit 3XL
• 00812277033922: *Custom* LMPD PPE Kit 2XL
• 00812277033915: *Custom* LMPD PPE Kit XL
• 00812277033908: *Custom* LMPD PPE Kit LG
• 00812277033892: *Custom* LMPD PPE Kit Med
• 00812277033878: *Custom* MUNICIPALITY OF ANCHORAGE FIRST AID
• 00812277033861: *Custom* Sky Harbor Bcon Kit w. SAM XT
• 00812277033854: *Custom* Sky Harbor Bcon Kit w. SWATT
• 00812277033847: Curaplex Hemorrhage Control Kit With Sam Xt Advanced
• 00812277033830: Curaplex Hemorrhage Control Kit With Swat-T Advanced
• 00812277033823: Curaplex hemorrhage control kit with SAM XT Basic
• 00812277033816: Curaplex Hemorrhage Control Kit With Swat-T Basic
• 00812277033809: *Custom* Area Metro ECG Electrode Kit
• 00812277033502: *Custom* Epi Kit Replacement Parts
• 00812277033496: *Custom* Burnsville Fire IV Start Kit
• 00812277033458: *Custom* South Metro Lancet Kit
• 00812277033441: *Custom* South Metro Nasal Cannula Kit
• 00812277033434: *Custom* South Metro non Rebreather Mask
• 00812277033427: *Custom* South Metro Small Volume Neb Kit
• 00812277033410: *Custom* South Metro 22ga Hypo Needle Kit
• 00812277033403: *Custom* South Metro 10cc Syringe Kit
• 00812277033397: *Custom* South Metro 3cc Syringe Kit
• 00812277033380: *Custom* South Metro 1cc Syringe Kit
• 00812277033083: *Custom* IV Start Kit with Neutral Clave Ext Set
• 00812277033076: *Custom* Wilkes Co IV Start Kit
• 00812277033069: *CUSTOM* South Metro IV Admin 10 drop kit
• 00812277033052: *CUSTOM* South Metro Introcan IV Catheter 24ga
• 00812277033045: *CUSTOM* South Metro Introcan IV Catheter 22ga
• 00812277033038: *CUSTOM* South Metro Introcan IV Catheter 20ga
• 00812277033021: *CUSTOM* South Metro Introcan IV Catheter 18ga
• 00812277033014: *CUSTOM* South Metro Introcan IV Catheter 16ga
• 00812277033007: *CUSTOM* South Metro Introcan IV Catheter 14ga
• 00812277032994: *CUSTOM* South Metro Blood Tube Kit
• 00812277032987: *CUSTOM*South Metro IV Start Kit
• 00812277032970: *CUSTOM*US Border Patrol Response Refill Kit
• 00812277032109: *CUSTOM*ATF non Medic Kit
• 00812277032093: *CUSTOM* Curaplex DuCanto Suction Kit
• 00812277032079: VibraPEP without T-piece Adapter
• 00812277032031: VibraPEP with T-piece Adapter
• 00812277032000: ClearPath Bypass HME
• 00812277031980: *CUSTOM* Multipack Hemorrhage Control Kit
• 00812277031973: *CUSTOM* Disney Vacuum Sealed Hemorrhage Control Kit
• 00812277031966: Stop The Bleed Basic Kit- *EMP FOR AMAZON ONLY*
• 00812277031959: *CUSTOM* Shelby Co Blood Draw Kit