FDA.reportPublic FDA data

Pertrach

Primary DI
00841470104375
Brand
Pertrach
Company
ENGINEERED MEDICAL SYSTEMS INC
Model
301-D4558
Published
2016-05-27
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
BTOTube, Tracheostomy (W/Wo Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTOTube, Tracheostomy (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914743000EMERGENCY PERCUTANEOUS CRICOTHYROIDOTOMY KIT,MODIFPertrach1992-07-10BTO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841470104372PackageGS15In Commercial Distribution
00841470104375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084147010437210841470104372
00841470104375008414701043758414701043750841470104375

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
Lumen/Inner Diameter5Millimeter

Contacts#

Phone, Email table
PhoneEmail
317-246-5500info@engmedsys.com

Regulatory Flags#

DUNS number
154502934
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841470106218ABC -Flex Tube SystemF060323M3X1E42025-04-11
00841470106263ABC - Uniflow Breathing CircuitU060323M1X1E42025-04-11
00841470106287ABC - Duoflow Bi-lumen Breathing CircuitD072323M2X1E42025-04-11
00841470106348ABC - Flex Tube SystemF060323M0X1E52025-04-11
00841470106577ABC - Compact Breathing CircuitC120323M0X1A42025-04-11
00841470106584ABC - Compact Breathing CircuitC120323M0X1E52025-04-11
00841470106737ABC - Duoflow Bi-lumen Breathing CircuitD072323M0X1A42025-04-11
00841470107116ABC - Uniflow Breathing CircuitU072323M0X1A42025-04-11
00841470107659ABC - Uniflow Breathing CircuitU096323M0X1A42025-04-11
00841470108625ABC - Flex Tube SystemF96M317M0X1A42025-04-11
00841470108731ABC - Duoflow Bi-lumen Breathing CircuitD12M317M1X1A42025-04-11
00841470108847ABC - Pediatric Compact Breathing CircuitPC12123M900002025-04-11
00841470108946ABC - Duoflow Bi-lumen Breathing CircuitD72M317M1X1A42025-04-11
00841470108953ABC - Pediatric Compact Breathing CircuitPC12113M0X5002025-04-11
00841470109455ABC - Compact Breathing CircuitC120323M0X1C52025-04-11
00841470109486ABC - Compact Breathing CircuitC072323M1X1A42025-04-11
00841470109493ABC - Compact Breathing CircuitC120323M1X1E52025-04-11
00841470109509ABC - Duoflow Bi-lumen Breathing CircuitD120323M1X1A42025-04-11
00841470109523ABC - Uniflow Breathing CircuitU072323M0X1002025-04-11
00841470109530ABC - Uniflow Breathing CircuitU072323M0X1E52025-04-11

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