FDA UDI
In Commercial Distribution
🇺🇸 United States
Pilot Tube Repair Kit
DI: M996BE4090
·
Model: BE 409
·
INSTRUMENTATION INDUSTRIES, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Pilot Tube Repair Kit
- Primary DI
- M996BE4090
- Version / Model
- BE 409
- Catalog Number
- BE 409
- Company Name
- INSTRUMENTATION INDUSTRIES, INCORPORATED
- Labeler DUNS
- 053146767
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-07-31
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 655a4a83-e7cc-452c-9015-7de492edfd78
Device Description
Pilot tube repair kit is used to repair a leaking pilot line of endotracheal and tracheostomy tubes with inside diameters of 0.032 inch (21 gauge) to 0.050 inch (18 gauge). Use of a pilot tube repair kit can delay the replacement of the endotracheal or tracheostomy tube thus reducing trauma to the patient.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BSK | Cuff, Tracheal Tube, Inflatable | Anesthesiology | 868.5750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37555 | Tracheal pilot tube repair kit | A collection of devices designed to restore the integrity of a damaged endotracheal (ET)/tracheostomy pilot tube when it is no longer maintaining the tracheal cuff pressure. Such a repair can deter the need to replace the entire endotracheal/tracheostomy tube because of a damaged pilot tube. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M996BE4090 | HIBCC | ||||
| Package | M996BE4092 | HIBCC | ziplock bag | 10 | In Commercial Distribution | |
| Package | M996BE4091 | HIBCC | ziplock bag | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- 412-854-1133
- [email protected]