FDA.report

Curaplex

Primary DI
00817617022765
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
301-0207
Catalog number
301-0207
Device description
*Custom* Airway Kit w/ BVM and Guedel Airway
Published
2017-02-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Product Code Classifications

CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817617022765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817617022765008176170227658176170227650817617022765

GMDN Terms

TermDefinition
Resuscitator face mask, single-useA non-sterile, flexible, form-shaped device that is placed over a patient's nose and mouth to direct ambient air, or medical oxygen (O2) and air, from a resuscitator to the upper airway and lungs. It is typically made of non-conductive sterilizable materials (e.g., silicone) that will create a gastight seal against the face. It will typically include a 15 mm and/or 22 mm connector and is available in a range of sizes (baby to adult). It will be directly attached to the resuscitator and held in place on the patient's face by the operator. This device is intended for use with a breathing resuscitator but may be used for the delivery of anaesthesia gases. This is a single-use device.

Sterilization Methods

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
false
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 DIBrandModelCatalogPublished
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
00199972000153Curaplex8600-015428600-015422026-01-23
00199972000160Curaplex8600-015438600-015432026-01-23
00199972000177Curaplex8600-015448600-015442026-01-23
00199972000184Curaplex8600-015458600-015452026-01-23
00199972000191Curaplex8600-015468600-015462026-01-23
00199972000207Curaplex8600-01546B8600-01546B2026-01-23
00199972000214Curaplex8600-015478600-015472026-01-23
00199972000221Curaplex8600-015488600-015482026-01-23
00199972000238Curaplex8600-015498600-015492026-01-23
00199972000016Curaplex Advanced Hemostatic Gauze4in x 4in (10cm x 10cm)CAHG-4X42025-12-17
00199972000030Curaplex Advanced Hemostatic Gauze3in x 1.6 Yds (7.6cm x 150 cm)CAHG-R52025-12-17
00199972000054Curaplex Advanced Hemostatic Gauze3in x 3.2Yds (7.6cm x 300 cm)CAHG-Z102025-12-17
00199972000078Curaplex®8600-015558600-015552025-12-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
16946430425208CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425215CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425222CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425239CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425246CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425253CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425260CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425277CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425284CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425291CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425307CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425314CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425321CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425338CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425345CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425352CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425369CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425376CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425383CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425390CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425406CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425413CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425420CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425437CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425444CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
45060112316102LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-12-10
35060112316112LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-11-17
00840117340428Resp-O2 Disposable Guedel Airway, 120 mm, Adult XX-Large, Lavender Dynarex CorporationCAE2025-09-29
25060112310618LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-09-11
15060112311038LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-09-11