FDA.reportPublic FDA data

NA

Primary DI
04055207014479
Brand
NA
Company
Richard Wolf GmbH
Model
8214128
Catalog number
8214.128
Device description
TRACHEAL SCOPE-TUBE ID 12MM model Hemer, OD 13mm, TL 300mm, with proximal illumination and sampling channel, without distal viewing window, graduated, reusable
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EOQBRONCHOSCOPE (FLEXIBLE OR RIGID)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207014479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207014479040552070144794055207014479

GMDN Terms#

Term, Definition table
TermDefinition
Basic endotracheal tube, reusableA hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated. The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is typically made of plastic or rubber and is available in various diameters and lengths for adult and paediatric patients. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter12Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide

Contacts#

Phone, Email table
PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags#

DUNS number
315304071
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04055207000649NA799000179900012021-04-05
04055207000656NA799000279900022021-04-05
04055207058862NA799000379900032021-04-05
04055207070055NA10300103.002024-06-03
04055207058886NA82295822952022-08-09
04055207038758FUSION DESIGN8095098095092022-03-08
04055207055199FUSION DESIGN8070028070022022-03-08
04055207065730VERTEBRIS1520826415208.2642022-11-01
04055207056585HIGHFLOW223560122356012017-07-21
04055207056592HIGHFLOW223561122356112017-07-21
04055207026526ERAGON BIPOLAR83930031839300312016-09-27
04055207026533ERAGON BIPOLAR83930032839300322016-09-27
04055207026540ERAGON BIPOLAR83930033839300332016-09-27
04055207026557ERAGON BIPOLAR83930034839300342016-09-27
04055207026564ERAGON BIPOLAR83930035839300352016-09-23
04055207026588ERAGON BIPOLAR83930041839300412016-09-27
04055207026724ERAGON BIPOLAR83930921839309212016-09-27
04055207033876ERAGON BIPOLAR8393001028393001022016-09-27
04055207055540ERAGON BIPOLAR83930037839300372016-09-27
04055207066805NA880888.082026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826920684PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826920899PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826920929PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826920950PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826925672PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926365PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926389PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926419PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926426PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926464PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926808PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926815PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926822PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926839PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926846PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926877PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926884PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926891PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926976PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926983PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926990PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826927003PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826927164PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826927218PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826928284PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826930935INSPIRAPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826930959INSPIRAPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04547410524642FUJIFILMFUJIFILM CORPORATIONEOQ2026-07-30
04547410524680FUJIFILMFUJIFILM CORPORATIONEOQ2026-07-30
06972084140634WiScope®Ningbo Wise Optomech Technology CorporationEOQ2026-07-28