FDA UDI
In Commercial Distribution
🇺🇸 United States
Go-PAP
DI: 00841470111519
·
Model: 313-4605NC
·
PULMODYNE INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Go-PAP
- Primary DI
- 00841470111519
- Version / Model
- 313-4605NC
- Company Name
- PULMODYNE INC
- Labeler DUNS
- 030619483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-12
- Public Version
- 1
- Public Version Date
- 2025-04-21
- Public Version Status
- New
- Public Device Record Key
- 6bc8e8e6-1ba6-4209-93cd-e664f879d39b
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | Anesthesiology | 868.5965 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64811 | In-line CPAP gas flow management unit, non-adjustable | A portable non-electronic device intended to mix ambient air with compressed oxygen (O2) to generate a flow of oxygen rich air to a patient at a pre-set (non-adjustable) inspired oxygen concentration (FiO2) [e.g., pre-set at 28-33%], for continuous positive airway pressure (CPAP) with oxygen, during noninvasive and invasive ventilation (i.e., capable of both). Also known as a CPAP flow generator, it includes an oxygen supply connection, ambient air inlet, and a patient outlet; it does not include any controls. CPAP pressure is defined by the PEEP valve used with this device. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10841470111516 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00841470111519 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Large |