FDA.report

Singer Laryngectomy Tube

Primary DI
34063107102005
Brand
Singer Laryngectomy Tube
Company
Boston Medical Products, Inc.
Model
SLT-1127
Catalog number
SLT-1127
Device description
Size: Size 11 x 27 mm
Published
2022-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KACTube, Laryngectomy

Product Code Classifications

CodeDeviceSpecialtyClass
KACTube, LaryngectomyEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34063107102005PackageGS11In Commercial Distribution
14063107102001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3406310710200534063107102005
1406310710200114063107102001

GMDN Terms

TermDefinition
Laryngectomy tubeA hollow device intended to maintain tracheostoma patency immediately after laryngectomy to provide an airway for the patient and to prevent tracheostomal stenosis (narrowing) in the months following the procedure. It is a soft plastic or silicone curved/contoured tube, similar to a tracheostomy tube, and may have an inner cannula and be fenestrated to allow simultaneous use with a tracheoesophageal speech valve. It is held in place with a strap or band around the neck and is typically regularly removed and reinserted by the patient. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length27Millimeter
Lumen/Inner Diameter13Millimeter
Outer Diameter16Millimeter

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
true
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

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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

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