FDA.reportPublic FDA data

N/A

Primary DI
14250105605096
Brand
N/A
Company
VBM Medizintechnik GmbH
Model
30-02-014-1
Device description
Jet-Ventilation Catheter for child
Published
2016-05-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K955461000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955461000TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).VBM Medizintechnik GmbH1997-03-19BTO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14250105605096PackageGS15In Commercial Distribution
04250105605099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1425010560509614250105605096
04250105605099042501056050994250105605099

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen administration transtracheal catheterA flexible tube intended to be introduced across the tracheal wall to provide supplementary oxygen (O2) to the respiratory tract of a person who is unable to breathe through the nose or mouth because of obstruction. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge14Gauge

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
324869601
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250105630770ScalpelCric30-08-447-12026-05-08
04250105623048n.a.33-80-650-12020-09-02
04250105624243n.a.33-81-650-12020-09-02
04250105605150Quicktrach I30-04-002-12026-04-23
04250105605167Quicktrach I30-04-004-12026-04-23
04250105612462Quicktrach I30-04-904-12026-04-23
04250105613292Quicktrach I30-04-902-12026-04-23
14250105606024Tourniquet 250015-12-5002022-06-27
04250105630459Ambu® SureSight TM Stylet; large3219000302025-07-02
04250105630442Ambu® SureSight TM Stylet; medium3219000202025-07-02
04250105630435Ambu® SureSight TM Stylet; small3219000102025-07-02
14250105630449Ambu® SureSight TM Stylet; medium3219000202025-07-02
14250105630456Ambu® SureSight TM Stylet; large32190002302025-07-02
04250105628111n.a.30-08-447-12020-11-09
14250105628118n.a.30-08-447-12020-11-09
14250105630524Paediatric Mask; Newborn88-11-0002025-04-25
14250105630531Paediatric Mask; Infant88-11-0012025-04-25
14250105630548Paediatric Mask; Child88-11-0022025-04-25
24250105630521Paediatric Mask; Newborn88-11-0002025-04-25
24250105630538Paediatric Mask; Infant88-11-0012025-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783010640Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010657Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010664Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010671Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010695Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010701Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010718Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010725Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010732Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010749Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010756Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010770Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010787Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010794Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010800Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010817Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010824Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010831Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010848Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010855Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010862Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010879Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010886Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010893Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010909Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010916Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010923Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010930Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010947Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010954Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09