FDA UDI
In Commercial Distribution
🇺🇸 United States
MicroAire®
DI: 00847399006172
·
Model: 9500-004
·
Microaire Surgical Instruments LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MicroAire®
- Primary DI
- 00847399006172
- Version / Model
- 9500-004
- Company Name
- Microaire Surgical Instruments LLC
- Labeler DUNS
- 103056420
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-30
- Public Version
- 1
- Public Version Date
- 2022-01-07
- Public Version Status
- New
- Public Device Record Key
- 63782d9a-4dc5-49d8-9c79-d6fdbaaf24b5
Device Description
OHIO/SCHRADER ADAPTER
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 |
|---|---|---|---|---|
| 37934 | Nitrogen quick-connect coupling, female | A female connecting device used to accept a male nitrogen (N2) connector to connect two devices together to provide a continuous passageway for the delivery of nitrogen. It has safety features such as a specific mechanical mating pattern, colour coding and a dedicated tube diameter connection to prevent wrong connection and allow a user to rapidly connect and disconnect nitrogen dependent devices. It can be attached, e.g., to a nitrogen regulator or a nitrogen extension tubing. It can be designed as a diameter-indexed safety system (DISS) connector or a non-interchangeable screw-threaded (NIST) connector. This is not a nitrogen terminal unit. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00847399006172 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -18 – 49 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 91 Percent (%) Relative Humidity