FDA UDI In Commercial Distribution 🇺🇸 United States

IV Start Kit

DI: 00616784469621 · Model: 4696 · DYNAREX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
IV Start Kit
Primary DI
00616784469621
Version / Model
4696
Company Name
DYNAREX CORPORATION
Labeler DUNS
008124539
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-05-04
Public Version
1
Public Version Date
2022-05-12
Public Version Status
New
Public Device Record Key
3b84ac5e-2711-4c7a-ba82-6abffa7d0fa3

Device Description

IV Start Kit, Stretch Vinyl Gloves, Sterile, 1 Tourniquet (3/4" x 18"), 2 Gauze Sponge (2" x 2", 8 Ply), 1 ID Label, 1 Pair of PVC Gloves in paper wrap, 1 Transparent Dressing, 1 Tape (3/4" x 18"), 1 PVP Pad, 1 Alcohol Pad

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
LRS I.V. Start Kit

GMDN Terms

Code Name
58977 Basic intravenous administration set, noninvasive

Identifiers

Type ID
Primary 00616784469621
Package 00616784469638