FDA UDI
In Commercial Distribution
🇺🇸 United States
MicroAire®
DI: 00847399018960
·
Model: ASP-TUBING
·
Microaire Surgical Instruments LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MicroAire®
- Primary DI
- 00847399018960
- Version / Model
- ASP-TUBING
- Company Name
- Microaire Surgical Instruments LLC
- Labeler DUNS
- 103056420
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-01
- Public Version
- 1
- Public Version Date
- 2025-08-11
- Public Version Status
- New
- Public Device Record Key
- a77ae725-385c-4159-bd9c-90d541a6376b
Device Description
VACUUM TUBING, 4PK, 5/8"OD x 3/8"ID x 3FT
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| QPB | System, Suction, Lipoplasty For Removal | General, Plastic Surgery | 878.5040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36984 | Methoxyflurane anaesthesia vaporizer | A device used to vaporize the anaesthetic agent methoxyflurane and deliver a controlled amount of the agent to a patient being prepared for surgery. The device is usually mounted to an anaesthesia system or ventilator. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00847399018960 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K242804 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 0.625 | Inch | |
| Lumen/Inner Diameter | 0.375 | Inch | |
| Length | 3 | Feet |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -18 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 90 Degrees Celsius