FDA UDI
In Commercial Distribution
🇺🇸 United States
VBMax30E, PF Testing Filter
DI: 00817081027969
·
Model: VBMax30E - 146304
·
A-M SYSTEMS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- VBMax30E, PF Testing Filter
- Primary DI
- 00817081027969
- Version / Model
- VBMax30E - 146304
- Catalog Number
- 146304
- Company Name
- A-M SYSTEMS, LLC
- Labeler DUNS
- 020275145
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-27
- Public Version
- 1
- Public Version Date
- 2025-02-04
- Public Version Status
- New
- Public Device Record Key
- 48f80a2e-829c-407f-a203-a7da3f6d72a9
Device Description
VBMax30E, Pulmonary Function Testing Filter, Labeled DR 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
- No
- 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 |
|---|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | Anesthesiology | 868.5260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61097 | Pulmonary function testing filter/mouthpiece | A non-sterile, portable, screening device intended to be used during pulmonary function testing to remove and retain microdroplets from patient breath to reduce contamination of the parent device; it is also intended to function as a mouthpiece to facilitate access to the patient’s respiratory tract. It is a bidirectional filter, typically in a plastic housing, with a proximal port/mouthpiece; it may have a basic mouthpiece portion capable of being attached to a separate dedicated mouthpiece. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00817081027976 | GS1 | 100 | In Commercial Distribution | ||
| Primary | 00817081027969 | GS1 |
Customer Contacts
- Phone
- 3606838300
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K000654 | 000 |