FDA.reportPublic FDA data

RUSCH

Primary DI
04026704111671
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN041863
Catalog number
120605050
Device description
EASYCRIC EMERGENCY CRICOTHYROTOMY SET, STERILE PACK
Published
2015-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BWCNeedle, emergency airway

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWCNeedle, Emergency AirwayAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130405000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130405000RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SETTeleflex Medical2013-11-06BWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704111675PackageGS11In Commercial Distribution
44026704111679PackageGS122In Commercial Distribution
04026704111671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670411167524026704111675
4402670411167944026704111679
04026704111671040267041116714026704111671

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length72Millimeter
Outer Diameter8.5Millimeter

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902172065ARROWIPN917285IAP-07002021-09-27
10801902187649ARROWIPN919474CS-12123-F2022-11-29
10801902215229ARROWIPN928089CS-12123-F2023-06-05
14026704633002DEKNATELIPN02854479-5562019-09-03
14026704633019DEKNATELIPN02854579-5602019-09-04
14026704633026DEKNATELIPN02854679-5982019-09-04
14026704633149DEKNATELIPN02855779-7752019-09-04
14026704633156DEKNATELIPN02855879-8122019-09-04
14026704633729DEKNATELIPN028759RC6-9702019-09-04
14026704633828DEKNATELIPN028581X-21612019-09-04
14026704633842DEKNATELIPN028658X-29722019-09-03
14026704633873DEKNATELIPN028583X-30192019-09-04
14026704633880DEKNATELIPN028763X-30272019-09-04
14026704633897DEKNATELIPN028764X-30942019-09-04
14026704633910DEKNATELIPN028584X-31422019-09-04
14026704633934DEKNATELIPN028766X-33412019-09-04
14026704633996DEKNATELIPN028769X-36342019-09-04
14026704634047DEKNATELIPN028773X-41942019-09-04
14026704634108DEKNATELIPN028661X-44342019-09-04
14026704634399DEKNATELIPN028776X-48842019-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250105630770ScalpelCricVBM Medizintechnik GmbHBWC2026-05-08
04250105629736ScalpelCricVBM Medizintechnik GmbHBWC2022-12-21
04250105628111n.a.VBM Medizintechnik GmbHBWC2020-11-09
14250105628118n.a.VBM Medizintechnik GmbHBWC2020-11-09
15019315110528PortexICU MEDICAL, INC.BWC2017-05-29
35019315110522PortexICU MEDICAL, INC.BWC2017-05-29
00827002077966PatilCOOK INCORPORATEDBWC2015-10-24
00827002082519ArndtCOOK INCORPORATEDBWC2015-10-24
00827002089501PatilCOOK INCORPORATEDBWC2015-10-24
00827002094130CookCOOK INCORPORATEDBWC2015-10-24
00827002103382CookCOOK INCORPORATEDBWC2015-10-24
15019315010989PortexICU MEDICAL, INC.BWC2015-09-01