FDA UDI
In Commercial Distribution
🇺🇸 United States
UM FFM
DI: 00619498606269
·
Model: 60626
·
RESMED PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- UM FFM
- Primary DI
- 00619498606269
- Version / Model
- 60626
- Catalog Number
- 60626
- Company Name
- RESMED PTY LTD
- Labeler DUNS
- 751149311
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-06
- Public Version
- 6
- Public Version Date
- 2024-02-05
- Public Version Status
- Update
- Public Device Record Key
- 16238603-1d8c-44c0-997c-45b4bfc4f852
Device Description
UM FFM SLM-SML STD
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
- Yes
- 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 |
|---|---|---|---|---|
| 60626 | Defibrinated blood dressing | A dermal wound covering made from woven material (e.g., cotton, viscose) impregnated with defibrinated bovine blood intended to promote physical haemostasis, act as barrier against infection, contamination, or injury, and reduce adherence to the wound. It typically includes a preservative (e.g., Clioquinol) and may have other additives (e.g. liquid paraffin, lanolin, and/or talcum); it is available in various forms (e.g., pad, ribbon). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00619498606269 | GS1 |
Customer Contacts
- Phone
- 800-424-0737
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit