FDA UDI
In Commercial Distribution
🇺🇸 United States
Mouthpiece, Disposable, White, Thermoplastic, Bite Block Style
DI: 00817081028225
·
Model: Disposable Mouthpiece, Bite Block Style - 164904
·
A-M SYSTEMS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Mouthpiece, Disposable, White, Thermoplastic, Bite Block Style
- Primary DI
- 00817081028225
- Version / Model
- Disposable Mouthpiece, Bite Block Style - 164904
- Catalog Number
- 164904
- Company Name
- A-M SYSTEMS, LLC
- Labeler DUNS
- 020275145
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-21
- Public Version
- 1
- Public Version Date
- 2025-03-03
- Public Version Status
- New
- Public Device Record Key
- 66f388d5-9f61-448f-9400-ac641aab6e50
Device Description
Mouthpiece, Disposable, White, Thermoplastic, Bite Block Style, D R Burton
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
- Yes
- 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 |
|---|---|---|---|---|
| BYP | Mouthpiece, Breathing | Anesthesiology | 868.5620 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44545 | Breathing mouthpiece, single-use | A device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid plastic hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. It is typically attached, either directly or through other tubes/adaptors, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser, breath collector); connectors and filters may be included with the device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00817081028232 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 00817081028225 | GS1 |
Customer Contacts
- Phone
- 3606838300
- [email protected]