FDA UDI
In Commercial Distribution
🇺🇸 United States
Spiration Valve System
DI: 00896506002217
·
Model: HUS-VSK
·
Gyrus Acmi, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Spiration Valve System
- Primary DI
- 00896506002217
- Version / Model
- HUS-VSK
- Company Name
- Gyrus Acmi, Inc.
- Labeler DUNS
- 117521967
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2021-03-04
- Public Version Status
- Update
- Public Device Record Key
- f72dc8d8-f59f-4820-9923-0182622df0d3
Device Description
Airway Sizing Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OAZ | One-Way Air-Leak Valve | Unknown | f |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58006 | Endobronchial airway sizing kit | A sterile collection of mechanical devices intended to be used with a balloon catheter for a planned intervention to determine the appropriate endobronchial valve sizes for a patient's lung airways (bronchial lumens). It typically consists of a glass syringe and a plastic calibration gauge with holes representing available endobronchial valve sizes. The syringe is used for filling the balloon with a medium (e.g., sterile saline). Using the same balloon catheter, the volume reading on the syringe made with the balloon in the airway is compared against the volume readings taken with the calibration gauge to select the proper valve size needed for an airway. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00896506002217 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| H060002 | 008 |