FDA UDI
In Commercial Distribution
🇺🇸 United States
Parker
DI: 00607411959509
·
Model: H-PSTDL-39
·
SALTER LABS
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Parker
- Primary DI
- 00607411959509
- Version / Model
- H-PSTDL-39
- Catalog Number
- H-PSTDL-39
- Company Name
- SALTER LABS
- Labeler DUNS
- 022721133
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-03
- Public Version
- 2
- Public Version Date
- 2022-12-20
- Public Version Status
- Update
- Public Device Record Key
- 4fcc7161-a0b8-4ea5-a9ba-a3730ba95069
Device Description
Parker Endo-Bronch with Standard Tip (Left Double-lumen Endobronchial Tube), PSTDL, 39 Fr, O.D 11.5mm, I.D 4.6mm Parker Original DID: 10749065851468 .
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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | Anesthesiology | 868.5740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37469 | Artificial airway stylet, single-use | A long stiffening wire/rod designed for insertion within the lumen of an artificial airway tube (e.g., endotracheal tube, bronchial tube) to stiffen and/or maintain the shape of the tube to facilitate introduction (intubation). It is designed to be slightly shorter than the tube to avoid damage to the airway during passage, and is withdrawn after intubation has been completed. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20607411959503 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 00607411959509 | GS1 | ||||
| Package | 10607411959506 | GS1 | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +8004210024
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092886 | 000 |