FDA UDI In Commercial Distribution 🇺🇸 United States

Pediatric Urine Collector

DI: 00616784428314 · Model: 4283 · DYNAREX CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
Pediatric Urine Collector
Primary DI
00616784428314
Version / Model
4283
Company Name
DYNAREX CORPORATION
Labeler DUNS
008124539
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-06-21
Public Version
1
Public Version Date
2021-06-29
Public Version Status
New
Public Device Record Key
70639142-0abb-4418-8b4a-25b12609213b

Device Description

Pediatric Urine Collector, 200mL

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
MR Safe
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
KNX Collector, Urine, (And Accessories) For Indwelling Catheter
EXI Device, Paste-On For Incontinence, Sterile

GMDN Terms

Code Name
65395 Wearable paediatric urine collection bag

Identifiers

Type ID
Package 00616784428321
Primary 00616784428314
Package 00616784428338