FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PEDIATRIC ULTRA FLEX®ANESTHESIA BREATHING CIRCUIT
DI: 00612649185965
·
Model: 21216P-61E
·
King Systems Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PEDIATRIC ULTRA FLEX®ANESTHESIA BREATHING CIRCUIT
- Primary DI
- 00612649185965
- Version / Model
- 21216P-61E
- Catalog Number
- 21216P-61E
- Company Name
- King Systems Corporation
- Labeler DUNS
- 009299017
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 6
- Public Version Date
- 2022-10-24
- Public Version Status
- Update
- Public Device Record Key
- f9ca97ea-0046-45a1-a7a7-aef0505c33b4
- Distribution End Date
- 2018-06-21
Device Description
PEDIATRIC ULTRA FLEX CIRCUIT 20/CS
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAI | Circuit, breathing (w connector, adaptor, y piece) | Anesthesiology | 868.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37704 | Anaesthesia breathing circuit, single-use | An assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00612649183091 | GS1 | 20 | Not in Commercial Distribution | 2018-06-21 | |
| Primary | 00612649185965 | GS1 |
Customer Contacts
- Phone
- +14107686464
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Pediatric |