Duns Number:039612668
Device Description: (25) ANTACID (2/PACKAGE)(25) IBUPROFEN (2/PACKAGE)(50) EXTRA-STRENGTH ACETAMINOPHEN (2/PAC (25) ANTACID (2/PACKAGE)(25) IBUPROFEN (2/PACKAGE)(50) EXTRA-STRENGTH ACETAMINOPHEN (2/PACKAGE)(25) ASPIRIN (2/PACKAGE)(75) COUGH DROPS(1) TRAUMA DRESSING(50) PLASTIC BANDAGE(25) FABRIC KNUCKLE BANDAGE(25) FABRIC FINGERTIP BANDAGE(25) GAUZE PAD (4) NON-STICK PAD(2) GAUZE ROLL - 2" X 6 YDS(1) GAUZE ROLL - 4" X 6 YDS.(2) TRIANGULAR BANDAGE (13) HAND SANITZER(8) EYE PAD WITH TAPE(10) STING WIPE(1) TOURNIQUET(1) WOUNDSEAL TOPICAL POWDER(2) CPROTECTOR(54) ANTISEPTIC TOWELETTE(25) ANTIBIOTIC OINTMENT(25) BURN CREAM(1) SINGLE USE SALINE(2) BURN DRESSING(2) INSTANT ICE PACK(2) FIRST AID TAPE(1) COHESIVE ELASTIC BANDAGE(100) COTTON SWAB(1) SAM SPLINT(4) ABSORBENT COMPRESS(4) NITRILE GLOVE 1(1) FIRST AID FACTS GUIDE(1) PLASTIC TWEEZERS(1) SCISSORS(1) ABSORBENT POWDER(1) BAG WITH SCOOP(1) BIOHAZARD BAG(1) BOUFFANT CAP(1) GOWN(2) NITRILE GLOVE 2(2) PAPER TOWEL(2) GERMICIDAL WIPE(1) DISPOSABLE FACE MASK WITH SHIELD
Catalog Number
-
Brand Name
ANSI First Aid Kit Class B+
Version/Model Number
H-8757
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CBP
Product Code Name
Valve, Non-Rebreathing
Public Device Record Key
76ee3a52-d7bf-4e63-8042-be8658b83439
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
January 30, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 8 |
2 | A medical device with a moderate to high risk that requires special controls. | 1 |
U | Unclassified | 2 |