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
14026704610904LMAIPN046748V1750152018-09-15
14026704610928LMAIPN046750V1750252018-09-15
14026704640277RUSCHIPN0499450044511002019-04-23
14026704641779RUSCHIPN0499380044311002019-04-24
14026704641793RUSCHIPN0499410044335002019-04-24
14026704641816RUSCHIPN0499430044490002019-04-24
14026704641823RUSCHIPN0499440044500502019-04-24
05060112311918LMAIPN046959V1250302018-09-15
10801902226119ARROWPR-45563-BASPR-45563-BAS2026-10-07
10841156111519TELEFLEXIPN93068158822025-06-12
10841156111540TELEFLEXIPN93068258842025-06-12
10841156111755TELEFLEXIPN93068358862025-06-12
10801902225907ARROWPR-45541-BASPR-45541-BAS2026-10-06
10801902226188ARROWIPNB00349SI-111422026-09-28
10801902226195ARROWIPNB00348SI-112422026-09-28
10801902228205ARROWIPNB00283ASK-45703-NCC32026-09-25
10801902228212ARROWIPNB00282ASK-45802-NCC2026-09-25
10801902228700ARROWCDC-09903-1ACDC-09903-1A2026-09-22
10801902228717ARROWCDA-42703-XPCN1ACDA-42703-XPCN1A2026-09-22
04026704916955RUSCHIPN9007315640002026-08-03

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