FDA UDI In Commercial Distribution 🇺🇸 United States

Flexitouch

DI: 00816305020106 · Model: PD32-U · Tactile Systems Technology, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Flexitouch
Primary DI
00816305020106
Version / Model
PD32-U
Company Name
Tactile Systems Technology, Inc.
Labeler DUNS
146295980
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-20
Public Version
3
Public Version Date
2022-11-01
Public Version Status
Update
Public Device Record Key
446f5b61-0d39-4cb5-a97f-4c46f5b0a6ef

Device Characteristics

Single Use
No
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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JOW Sleeve, Limb, Compressible
PPS Sleeve, Head And Neck, Compressible

GMDN Terms

Code Name
44784 Intermittent venous compression system pump

Identifiers

Type ID
Primary 00816305020106