FDA UDI
Not in Commercial Distribution
🇺🇸 United States
JOHN BUNN
DI: M368GF813701
·
Model: GF81370
·
GF HEALTH PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
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Basic Information
- Brand Name
- JOHN BUNN
- Primary DI
- M368GF813701
- Version / Model
- GF81370
- Company Name
- GF HEALTH PRODUCTS, INC.
- Labeler DUNS
- 132016168
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2022-08-19
- Public Version
- 2
- Public Version Date
- 2025-10-27
- Public Version Status
- Update
- Public Device Record Key
- 0b6385db-cfdf-4de1-b230-c01c30a02311
- Distribution End Date
- 2023-05-23
Device Description
Mouthpiece, 22 mm
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | Anesthesiology | 868.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43467 | Breathing mouthpiece, reusable | 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 hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. The device accepts or attaches to, either directly or through other tubes/adapters, diagnostic/therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser). Some types generate a whistling sound to guide effective inhalation [e.g., during use of a metered dose inhaler (MDI)]. This is a reusable device which may be intended for single- or multi-patient use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M368GF813702 | HIBCC | Box | 40 | Not in Commercial Distribution | 2023-05-23 |
| Primary | M368GF813701 | HIBCC | ||||
| Unit of Use | M368GF813700 | HIBCC |
Customer Contacts
- Phone
- 770-368-4700
- [email protected]