FDA UDI
In Commercial Distribution
🇺🇸 United States
S8
DI: 00619498339198
·
Model: 33919
·
RESMED PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- S8
- Primary DI
- 00619498339198
- Version / Model
- 33919
- Catalog Number
- 33919
- Company Name
- RESMED PTY LTD
- Labeler DUNS
- 751149311
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-14
- Public Version
- 5
- Public Version Date
- 2023-08-29
- Public Version Status
- Update
- Public Device Record Key
- a5281579-2aa4-414b-88bc-44b6496298c4
Device Description
S8/TYPE A HYPO FILTERS
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | 868.5905 | 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 | 00619498339198 | GS1 | ||||
| Package | 00619498339228 | GS1 | 50 | In Commercial Distribution | ||
| Package | 00619498339761 | GS1 | 12 | In Commercial Distribution | ||
| Package | 00619498339754 | GS1 | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- 800-424-0737
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K071171 | 000 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit