FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Breathing Bag
DI: 00709078011702
·
Model: 8841
·
WESTMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Breathing Bag
- Primary DI
- 00709078011702
- Version / Model
- 8841
- Company Name
- WESTMED, INC.
- Labeler DUNS
- 092673953
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-30
- Public Version
- 3
- Public Version Date
- 2024-05-17
- Public Version Status
- Update
- Public Device Record Key
- b3f4b72b-807f-4653-a56a-25a5dce21b7a
- Distribution End Date
- 2024-05-17
Device Description
Breathing Bag, 3L, Not Made With Latex, W/Norman Gas Elbow
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
- Yes
- 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 |
|---|---|---|---|---|
| BTC | Bag, Reservoir | Anesthesiology | 868.5320 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34877 | Breathing circuit bag, single-use | A non-sterile elastomeric reservoir sac intended to store breathing gas during the respiratory cycle. The breathing bag may be on the inspiratory or expiratory limb of a breathing circuit depending on the breathing circuit design. It may also function as a maximum pressure limiting device during spontaneous or manually assisted ventilation. It may be made of conductive or non-conductive material and is typically used in anaesthesia or ventilator breathing circuits. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10709078011709 | GS1 | Case | 50 | Not in Commercial Distribution | 2024-05-17 |
| Primary | 00709078011702 | GS1 |