FDA.reportPublic FDA data

Quicktrach I

Primary DI
04250105605167
Brand
Quicktrach I
Company
VBM Medizintechnik GmbH
Model
30-04-004-1
Device description
Quicktrach: 15 mm O.D.; Canula: 4.0 mm I.D.;Tubing: 15 mm O.D., 15 mm I.D. / 22 mm O.D.
Published
2026-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K874742000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K874742000QUICKTRACHPosey Co.1987-12-31BTO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14250105605164PackageGS11In Commercial Distribution
04250105605167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1425010560516414250105605164
04250105605167042501056051674250105605167

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
Outer Diameter15Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight and heat.
Special Storage Condition, Specify00Keep dry.

Contacts#

Phone, Email table
PhoneEmail
+49745495960info@vbm-medical.de

Regulatory Flags#

DUNS number
324869601
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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