FDA UDI In Commercial Distribution 🇺🇸 United States

Parker

DI: 00607411959493 · Model: H-PSTDL-37 · SALTER LABS
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
Parker
Primary DI
00607411959493
Version / Model
H-PSTDL-37
Catalog Number
H-PSTDL-37
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
8e51eafa-22e2-4994-91a1-095b08bca2d4

Device Description

Parker Endo-Bronch with Standard Tip (Left Double-lumen Endobronchial Tube), PSTDL, 37 Fr, O.D 11.5mm, I.D 4.4mm Parker Original DID: 10749065851444 .

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
CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

GMDN Terms

Code Name
37469 Artificial airway stylet, single-use

Identifiers

Type ID
Package 20607411959497
Primary 00607411959493
Package 10607411959490

Customer Contacts

Phone
+8004210024

Premarket Submissions

Submission Number Supplement Number
K092886 000