FDA UDI
In Commercial Distribution
🇺🇸 United States
MAXAIR
DI: 00850078013002
·
Model: 2281PRS-100
·
Syntech, Int'l Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- MAXAIR
- Primary DI
- 00850078013002
- Version / Model
- 2281PRS-100
- Catalog Number
- 2281PRS-100
- Company Name
- Syntech, Int'l Inc.
- Labeler DUNS
- 078715452
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-14
- Public Version
- 1
- Public Version Date
- 2026-01-22
- Public Version Status
- New
- Public Device Record Key
- 159d2244-2fdb-4eef-b1a5-8642f4314939
Device Description
Hood with Filter
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FYA | Gown, Surgical | General, Plastic Surgery | 878.4040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35091 | Surgical gown, single-use | A garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850078013002 | GS1 | ||||
| Package | 10850078013009 | GS1 | 20 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040485 | 000 |