FDA UDI
In Commercial Distribution
🇺🇸 United States
INCENTIVE SPIROMETER,600/900/1200ML
DI: 04716770931005
·
Model: TB-93100
·
BESMED HEALTH BUSINESS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INCENTIVE SPIROMETER,600/900/1200ML
- Primary DI
- 04716770931005
- Version / Model
- TB-93100
- Company Name
- BESMED HEALTH BUSINESS CORP.
- Labeler DUNS
- 658023775
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-06
- Public Version
- 4
- Public Version Date
- 2023-11-17
- Public Version Status
- Update
- Public Device Record Key
- 23d14c05-cd8f-4bdd-b264-33802bb3648d
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BWF | Spirometer, Therapeutic (Incentive) | Anesthesiology | 868.5690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31266 | Incentive spirometer | A hand-held, mechanical, breathing-muscle exerciser intended to be used in respiratory therapy to encourage and motivate deep-breathing manoeuvres, typically for the postsurgical treatment and prevention of atelectasis (lung collapse) and to help facilitate airway opening and clearing. It includes an indicator in a housing that rises in relation to patient inspiratory effort, performed via an attached tube and mouthpiece, to determine the maximum volume of gas which can be inspired [i.e., the inspiratory vital capacity (IVC)]. This is a single-patient device designed for use in a medical facility and in the home. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04716770931005 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133873 | 000 |