FDA.reportPublic FDA data

Curaplex

Primary DI
00815277029797
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
8600-ADUNRB-1376
Catalog number
8600-ADUNRB-1376
Device description
*Custom* Memphis Adult NRB Kit
Published
2018-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KGBMASK, OXYGEN, NON-REBREATHING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGBMask, Oxygen, Non-RebreathingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815277029797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277029797008152770297978152770297970815277029797

GMDN Terms#

Term, Definition table
TermDefinition
Aerosol face mask, non-rebreathingA flexible, form-shaped device that is placed over the nose and mouth to deliver air, oxygen (O2), or a mixture of the two gases, with aerosolized particles, to a patient's airway. It includes two unidirectional valves, one that closes during inspiration to prevent room air from mixing with the O2 in the reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of high-grade resins or other materials to produce a soft, flexible mask that will create an airtight seal against the patient's face. It typically includes a headstrap and is available in a range of sizes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070556204
Device count
1
DM exempt
true
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
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344009609HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344009616HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344011473HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344011480HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344011503HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344011817HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344042187HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
008171360277157450 RV2 MASKHANS RUDOLPH, INC.KGB2025-09-19
07045432118179Pocket Mask, PB (DE FR ES IT EN)Laerdal Medical ASKGB2025-08-27
07045432118285Pocket Mask, SP Blue (DE FR ES IT EN)Laerdal Medical ASKGB2025-08-27
07045432119244Pocket Mask, HC Yellow (DE FR ES IT EN)Laerdal Medical ASKGB2025-08-27
07045432118186Pocket Mask, PB (EN)Laerdal Medical ASKGB2025-08-25
07045432118230Pocket Mask, SP Blue (EN)Laerdal Medical ASKGB2025-08-25
07045432119282Pocket Mask, HC White Private LabelLaerdal Medical ASKGB2025-08-25
07045432119305Pocket Mask, SP Black Private LabelLaerdal Medical ASKGB2025-08-25
07045432119329Pocket Mask, SP Camo Private LabelLaerdal Medical ASKGB2025-08-25
07045432119770Pocket Mask, HC Yellow (EN)Laerdal Medical ASKGB2025-08-25
07045432119251Pocket Mask O2, PB (DE FR ES IT EN)Laerdal Medical ASKGB2025-07-29
07045432119268Pocket Mask O2, SP Blue (DE FR ES IT EN)Laerdal Medical ASKGB2025-07-29
07045432119275Pocket Mask O2,HC Yellow (DE FR ES IT EN)Laerdal Medical ASKGB2025-07-29
07045432119299Pocket Mask O2, HC White Private LabelLaerdal Medical ASKGB2025-07-29
07045432119312Pocket Mask O2, SP Black Private LabelLaerdal Medical ASKGB2025-07-29
07045432119336Pocket Mask O2, SP Camo Private LabelLaerdal Medical ASKGB2025-07-29
07045432119879Pocket Mask O2,HC Yellow (EN)Laerdal Medical ASKGB2025-07-29
07045432119947Pocket Mask O2, PB (EN)Laerdal Medical ASKGB2025-07-29
07045432120004Pocket Mask O2, SP Blue (EN)Laerdal Medical ASKGB2025-07-29
00840117345232Resp-O2 Non-Rebreather Elongated Mask, Pediatric, With Safety Vent, 7' (2.1m) Dynarex CorporationKGB2025-05-30
00840117345249Resp-O2 Non-Rebreather Elongated Mask, Adult, 7' (2.1m) Crush-Resistant Tubing Dynarex CorporationKGB2025-05-30
00840117345256Resp-O2 Non-Rebreather Elongated Mask, Pediatric, 7' (2.1m) Crush-Resistant Dynarex CorporationKGB2025-05-30
00840117345263Resp-O2 Non-Rebreather Elongated Mask, Infant 7' (2.1m) Crush-Resistant Tubing Dynarex CorporationKGB2025-05-30