Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008384548

FEI Number

3008384548

Entity Name

ACTIVE-ICE, INC.

City/State/Country

Norman, OK, US

Establishment Address

3650 Classen Blvd, Norman, OK 73071, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Active-Ice, Inc. (Owner Number: 10053061)

Owner / Operator Contact Address

3650 Classen Blvd, Norman, OK 73071, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Active Ice Shower Shield

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2016-10-27
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2022-08-30

Official Correspondent

Devin Grunder Grunder

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Active-Ice, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Similar Registrations

Registration Number	Establishment Name	Location
3037007193	SHANGHAI HUIZHOU INDUSTRIAL CO., LTD	Shanghai City District, CN
3031182683	NINGBO YAMAI INDUSTRY AND TRADE CO., LTD.	Yuyao Zhejiang, CN
3016711531	BRANCH IN PHU THO, THYGESEN TEXTILE VIETNAM COMPANY LIMITED	Yen Lap Commune Phu Tho, VN
3002393819	MEDICAL SPECIALTIES OF CALIFORNIA LIMITED	Orpington Kent, GB
3038195249	SHENZHEN KADUO INDUSTRIAL CO., LTD	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008384548. Last updated year: 2026. Please use registration number 3008384548 when referencing this establishment in official correspondence.