FDA UDI
In Commercial Distribution
🇺🇸 United States
MicroAire®
DI: 00847399005960
·
Model: 9000-000
·
Microaire Surgical Instruments LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MicroAire®
- Primary DI
- 00847399005960
- Version / Model
- 9000-000
- Company Name
- Microaire Surgical Instruments LLC
- Labeler DUNS
- 103056420
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-17
- Public Version
- 1
- Public Version Date
- 2022-09-26
- Public Version Status
- New
- Public Device Record Key
- 199aba52-5964-4fa7-9281-8b28f01831b2
Device Description
PNEUMATIC AIR HOSE, MICROAIRE CONNECTOR
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37869 | Pneumatic surgical power tool hose | A single- or double-lumen (coaxial) tube in a straight or spiral design intended to be used to conduct compressed surgical-grade air or nitrogen (N2) gas from a gas source, usually the central medical gas supply system, to a surgical drilling system or sawing system handpiece or motor to supply it with power. The device is usually from 2 to 5 meters in length and is commonly designed according to ISO5359. The coaxial types have a double tube (inner and outer tubing) to facilitate the removal of the exhaust gases. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00847399005960 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 3 | Meter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -18 – 49 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 0 – 91 Percent (%) Relative Humidity