FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 04710810115639
·
Model: BC22
·
GALEMED CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- N/A
- Primary DI
- 04710810115639
- Version / Model
- BC22
- Catalog Number
- AN0019
- Company Name
- GALEMED CORPORATION
- Labeler DUNS
- 656854379
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-05
- Public Version
- 1
- Public Version Date
- 2026-03-13
- Public Version Status
- New
- Public Device Record Key
- 1fb98356-0158-4532-a181-a9e2649a549c
Device Description
PLS Valve, 10cmH2O, 22F
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
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | 868.5905 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34142 | Pressure relief valve, single-use | A non-sterile device used to regulate the maximum pressure level in a circuit or system (typically containing gas) where it is essential not to exceed a pre-set maximum pressure. Should this pressure level be exceeded, this device will automatically open and vent the excess pressure from the circuit/system ensuring that an excessive pressure level is not sustained, thereby preventing damage to the patient or a parent device. It is typically used in anaesthesia machines and ventilators forming part of the breathing/gas delivery circuit/system, but may be applied to other functions. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 44710810115637 | GS1 | Carton | 48 | In Commercial Distribution | |
| Primary | 04710810115639 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K110383 | 000 |