FDA.report

Hebeler Safe-T-Tube™

Primary DI
EBES4500180
Brand
Hebeler Safe-T-Tube™
Company
BOSTON MEDICAL PRODUCTS, INC.
Model
450018
Catalog number
450018
Device description
Size: 18 mm
Published
2015-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BTRTube, Tracheal (W/Wo Connector)

Product Code Classifications

CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EBES4500181PackageHIBCC1Not in Commercial Distribution
EBES4500180PrimaryHIBCC0

GMDN Terms

TermDefinition
Trachea prosthesisAn implantable artificial substitute for the natural trachea used in airway reconstructive surgery. It is typically a semi-rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal trachea prosthesis may be uncovered or covered with a polymeric material.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-433-2674info@bosmed.com

Regulatory Flags

DUNS number
131855157
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 DIBrandModelCatalogPublished
14063107102865Montgomery® Safe-T-Tube™ Plug/Ring Set3610863610862024-09-28
14063107102872Montgomery® Safe-T-Tube™ 15 mm Adaptor3610873610872024-09-28
14063107102889Montgomery® Safe-T-Tube™ Plug/Ring Set3611063611062024-09-28
14063107102896Montgomery® Safe-T-Tube™ 15 mm Adaptor3611073611072024-09-28
14063107102902Montgomery® Safe-T-Tube™ Plug/Ring Set3611163611162024-09-28
14063107102919Montgomery® Safe-T-Tube™ 15 mm Adaptor3611173611172024-09-28
14063107102926Montgomery® Safe-T-Tube™ Plug/Ring Set3611263611262024-09-28
14063107102933Montgomery® Safe-T-Tube™ 15 mm Adaptor3611273611272024-09-28
14063107102940Montgomery® Safe-T-Tube™ Plug/Ring Set3611463611462024-09-28
14063107102957Montgomery® Safe-T-Tube™ 15 mm Adaptor3611473611472024-09-28
14063107103060Montgomery® Safe-T-Tube™4600084600082024-09-28
14063107103077Montgomery® Safe-T-Tube™460008R460008R2024-09-28
14063107103084Montgomery® Safe-T-Tube™4600094600092024-09-28
14063107103091Montgomery® Safe-T-Tube™460009R460009R2024-09-28
14063107103107Montgomery® Safe-T-Tube™4600104600102024-09-28
14063107103114Montgomery® Safe-T-Tube™460010R460010R2024-09-28
14063107103121Montgomery® Safe-T-Tube™4600114600112024-09-28
14063107103138Montgomery® Safe-T-Tube™460011R460011R2024-09-28
14063107103145Montgomery® Safe-T-Tube™4600124600122024-09-28
14063107103152Montgomery® Safe-T-Tube™460012R460012R2024-09-28

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
24026704941043SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941057SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941064SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
24026704941074SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
24026704941081SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941095SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941101SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941118SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
24026704941128SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941132SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941149SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
44026704617195TELEFLEXTELEFLEX INCORPORATEDBTR2025-11-20
44026704617201TELEFLEXTELEFLEX INCORPORATEDBTR2025-11-20
34026704617211TELEFLEXTELEFLEX INCORPORATEDBTR2025-11-20
34026704617235TELEFLEXTELEFLEX INCORPORATEDBTR2025-11-20
44026704617911HUDSON RCITELEFLEX INCORPORATEDBTR2025-11-20
34026704930976SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704930983SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704930990SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
24026704931006SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
24026704931013SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704931027SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
24026704931037SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704931041SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704931058SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704931065SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
05055788776246ProVu Video StyletFLEXICARE MEDICAL LIMITEDBTR2025-05-30
05055788776260ProVu Video StyletFLEXICARE MEDICAL LIMITEDBTR2025-05-30
05055788776284ProVu Video StyletFLEXICARE MEDICAL LIMITEDBTR2025-05-30
05055788776307ProVu Video StyletFLEXICARE MEDICAL LIMITEDBTR2025-05-30