FDA UDI
In Commercial Distribution
🇺🇸 United States
SPIRO
DI: 07350061231350
·
Model: 740
·
Fogless International AB
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- SPIRO
- Primary DI
- 07350061231350
- Version / Model
- 740
- Catalog Number
- 740-25K; 740-100K
- Company Name
- Fogless International AB
- Labeler DUNS
- 356432815
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-31
- Public Version
- 3
- Public Version Date
- 2023-04-05
- Public Version Status
- Update
- Public Device Record Key
- dcb1c5aa-1f27-4a8d-a376-a054672623b2
Device Description
SPIRO Filter
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JOH | Tube Tracheostomy And Tube Cuff | Anesthesiology | 868.5800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37597 | Heat/moisture exchanger insertable filter | A dedicated membrane that is inserted into a reusable heat & moisture exchanger (HME) to capture a patient's exhaled heat and moisture, so that they can be used to heat and humidify therapeutic gases inspired by the patient typically during anaesthesia or intensive care ventilation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350061231350 | GS1 | ||||
| Package | 07350061231251 | GS1 | Zip-Lock Bag | 100 | In Commercial Distribution | |
| Package | 07350061231244 | GS1 | Zip-Lock Bag | 25 | In Commercial Distribution | |
| Package | 07350061231398 | GS1 | Paper Carton | 1 | In Commercial Distribution | |
| Package | 07350061231381 | GS1 | Paper Carton | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +4636144100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K122932 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a dark and dry environment at normal indoor room temperature