FDA UDI
In Commercial Distribution
🇺🇸 United States
Gas Sampling Elbow with Cap
DI: 00636207315335
·
Model: VMPELBO
·
Global Life Sciences Solutions USA LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Gas Sampling Elbow with Cap
- Primary DI
- 00636207315335
- Version / Model
- VMPELBO
- Catalog Number
- VMPELBO
- Company Name
- Global Life Sciences Solutions USA LLC
- Labeler DUNS
- 011658242
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-29
- Public Version
- 10
- Public Version Date
- 2026-02-23
- Public Version Status
- Update
- Public Device Record Key
- 177518ab-85aa-4e48-a214-d7c36a7ca299
Device Description
Gas Sampling Elbow with Cap
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
- Yes
- 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 |
|---|---|---|---|---|
| 61346 | Straight/elbow breathing circuit connector, single-use | A device intended to create a direct connection between a breathing circuit breathing tube and an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with specific connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It is typically made of plastic materials and can have a straight or elbow-shaped design (excludes Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30636207315336 | GS1 | case | 50 | In Commercial Distribution | |
| Primary | 00636207315335 | GS1 |
Customer Contacts
- Phone
- +1(800)645-6578 ext. 5164843600
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K013093 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 15 mm - 22 mm filter/elbow connection with gas sampling port and standard luer lock connector |