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
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

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