FDA.reportPublic FDA data

Curaplex

Primary DI
00812277035957
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
351631-A
Catalog number
351631-A
Device description
Curaplex CRICOTHYROTOMY FIELD KIT 6.0 MM 10EA/CS KWIK CRIC MVP
Published
2019-12-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
OGPCricothyrotomy kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGPCricothyrotomy KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812277035957PackageGS110In Commercial Distribution
00812277035896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812277035957008122770359578122770359570812277035957
00812277035896008122770358968122770358960812277035896

GMDN Terms#

Term, Definition table
TermDefinition
Cricothyrotomy kit, single-useA collection of sterile devices designed to perform a cricothyrotomy (an incision through the skin and cricothyroid) providing airway access within seconds allowing for immediate ventilation of the patient and necessary suction procedures. It is used to open a patient's airway in emergency interventions, e.g., accidental blockage to the upper airway tract, and prior to tracheostomy. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070556204
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810094575809Curaplex680152-KIT680152-KIT2023-04-30
00815277028059Curaplex8600-ATFMLOK2016-12-14
00815277029377Curaplex680150-KIT680150-KIT2018-12-15
01999720000003Curaplex Advanced Hemostatic Gauze4in x 4in(10cm x 10cm)CAHG-4X42025-11-25
01999720000027Curaplex Advanced Hemostatic Gauze3in x 1.6 Yds (7.6cm x 150 cm)CAHG-R52025-11-25
01999720000041Curaplex Advanced Hemostatic Gauze3in x 3.2Yds (7.6cm x 300 cm)CAHG-Z102025-11-25
01999720000065Curaplex®8600-015558600-015552025-11-13
01999720000263Curaplex670070-KIT670070-KIT2025-11-25
00810071638619CURAPLEXS1137301-S11372023-03-30
00817617023052Curaplex3141-910103141-910102017-09-04
00817617023069Curaplex3141-910123141-910122017-09-04
00817617023083Curaplex3141-910143141-910142017-09-04
00817617023335Curaplex36111361112017-09-04
00199972000085Curaplex8600-015358600-015352026-01-23
00199972000092Curaplex8600-015368600-015362026-01-23
00199972000108Curaplex8600-015378600-015372026-01-23
00199972000115Curaplex8600-015388600-015382026-01-23
00199972000122Curaplex8600-015398600-015392026-01-23
00199972000139Curaplex8600-015408600-015402026-01-23
00199972000146Curaplex8600-015418600-015412026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842209138586NARNORTH AMERICAN RESCUE, LLCOGP2026-04-22
10198956284685CARDINAL HEALTHCardinal Health 200, LLCOGP2026-01-16
50198956284683CARDINAL HEALTHCardinal Health 200, LLCOGP2026-01-16
00850063404433ForwardSynchronis Medical, LLCOGP2025-12-31
00850063404440ForwardSynchronis Medical, LLCOGP2025-12-31
M689HHECT01040Emergency Cric KitSafeguard US Operating, LLCOGP2025-12-19
10198956257818CARDINAL HEALTHCardinal Health 200, LLCOGP2025-12-11
50198956257816CARDINAL HEALTHCardinal Health 200, LLCOGP2025-12-11
00850070635066Endotracheal KitNar Medical Depot, LLCOGP2025-12-01
00850062467132Universal Stylette Bougie Assisted Cricothyrotomy (USBCR)Altitude Technologies Inc.OGP2025-08-04
00860009615564Endotracheal KitNar Medical Depot, LLCOGP2025-07-21
10198956054233CARDINAL HEALTHCardinal Health 200, LLCOGP2025-05-29
50198956054231CARDINAL HEALTHCardinal Health 200, LLCOGP2025-05-29
00842209135066NARNORTH AMERICAN RESCUE, LLCOGP2025-05-21
00842209133789NARNORTH AMERICAN RESCUE, LLCOGP2024-12-18
00842209130597NARNORTH AMERICAN RESCUE, LLCOGP2024-03-13
00842209130337NARNORTH AMERICAN RESCUE, LLCOGP2024-02-28
00842209130368NARNORTH AMERICAN RESCUE, LLCOGP2024-02-28
00842209129690TACTICAL CricKITNORTH AMERICAN RESCUE, LLCOGP2024-01-17
00842209129249TACTICAL CricKITNORTH AMERICAN RESCUE, LLCOGP2023-11-16
00842209128327NARNORTH AMERICAN RESCUE, LLCOGP2023-08-24
00842209127658NARNORTH AMERICAN RESCUE, LLCOGP2023-06-29
00842209127665NARNORTH AMERICAN RESCUE, LLCOGP2023-06-29
00842209127481NARNORTH AMERICAN RESCUE, LLCOGP2023-06-13
00842209127580NARNORTH AMERICAN RESCUE, LLCOGP2023-06-13
00842209126576NARNORTH AMERICAN RESCUE, LLCOGP2023-03-22
00842209126590NARNORTH AMERICAN RESCUE, LLCOGP2023-03-22
10197106110959CARDINAL HEALTHCardinal Health 200, LLCOGP2023-02-22
50197106110957CARDINAL HEALTHCardinal Health 200, LLCOGP2023-02-22
M689HHSCK01EA020Simplified Cricothyrotomy KitSafeguard US Operating, LLCOGP2022-08-10