FDA UDI
In Commercial Distribution
🇺🇸 United States
FISHER & PAYKEL HEALTHCARE
DI: 09420012430076
·
Model: RD1360-10
·
FISHER & PAYKEL HEALTHCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- FISHER & PAYKEL HEALTHCARE
- Primary DI
- 09420012430076
- Version / Model
- RD1360-10
- Catalog Number
- RD1360-10
- Company Name
- FISHER & PAYKEL HEALTHCARE LIMITED
- Labeler DUNS
- 590153276
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-25
- Public Version
- 5
- Public Version Date
- 2026-03-30
- Public Version Status
- Update
- Public Device Record Key
- 5d164be0-b8b1-452a-97d5-3b8305ed413e
Device Description
Ergonomic T-Piece Circuit with Mask 60mm
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
- No
- 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 |
|---|---|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | Anesthesiology | 868.5925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63534 | Inspiratory/expiratory limb respiratory tubing, single-use | A length of tube made of durable materials (e.g., rubber, silicone) intended to be used to conduct breathing gases towards or away from a patient during the respiratory cycle, typically during anaesthesia or ventilation [including continuous or bi-level positive airway pressure ventilation (CPAP or BPAP)]. It is intended to function as part of a breathing circuit and/or with other separate gas delivery devices (e.g., inhalational analgesia gas administration set, respiratory mask); connectors may be included with the device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09420012430076 | GS1 | ||||
| Package | 09420012424242 | GS1 | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 1 800 446 3908
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K892885 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius