FDA UDI In Commercial Distribution 🇺🇸 United States

InfiltraLong 700

DI: 04048223130834 · Model: 001158-30C · Pajunk GmbH Medizintechnologie
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
InfiltraLong 700
Primary DI
04048223130834
Version / Model
001158-30C
Catalog Number
001158-30C
Company Name
Pajunk GmbH Medizintechnologie
Labeler DUNS
317654283
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-07-30
Public Version
3
Public Version Date
2025-09-25
Public Version Status
Update
Public Device Record Key
f3c4b303-2ef4-41d1-846c-7b2a0f71fd9f

Device Description

InfiltraLong 700 InfiltraLong catheter 19G x 700mm with integrated metal spiral with 88 drill

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
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
BSO CATHETER, CONDUCTION, ANESTHETIC

GMDN Terms

Code Name
46383 Peripheral anaesthesia catheter set, non-medicated

Identifiers

Type ID
Package 04048223132210
Primary 04048223130834
Previous 04048223049624

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K080675 000

Storage Conditions

Type
Storage Environment Humidity
Temperature Range
20 – 65 Percent (%) Relative Humidity
Type
Storage Environment Temperature
Temperature Range
10 – 30 Degrees Celsius