FDA UDI
In Commercial Distribution
🇺🇸 United States
2 LITER CONTOUR®
DI: 00612649188225
·
Model: 30902Z
·
King Systems Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- 2 LITER CONTOUR®
- Primary DI
- 00612649188225
- Version / Model
- 30902Z
- Catalog Number
- 30902Z
- Company Name
- King Systems Corporation
- Labeler DUNS
- 009299017
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-13
- Public Version
- 1
- Public Version Date
- 2022-12-21
- Public Version Status
- New
- Public Device Record Key
- ba9d850d-1b97-4305-b3c9-855b5e52f0bd
Device Description
BAG,2 LITER CONTOUR LATEX FREE
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
- 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 |
|---|---|---|---|---|
| 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 | 00612649140834 | GS1 | 30 | In Commercial Distribution | ||
| Primary | 00612649188225 | GS1 |
Customer Contacts
- Phone
- +14107686464
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Adult |