FDA.report

Curaplex

Primary DI
00817617028255
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
6700139-KIT
Catalog number
6700139-KIT
Device description
*Custom* PHI Surgical Cric Kit
Published
2017-09-18
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
FOZCatheter,intravascular,therapeutic,short-term less than 30 days

Product Code Classifications

CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810094570576PackageGS135In Commercial Distribution
00817617028255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094570576008100945705768100945705760810094570576
00817617028255008176170282558176170282550817617028255

GMDN Terms

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

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

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00199972000177Curaplex8600-015448600-015442026-01-23
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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

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